Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CAST CUTTER BLADE 63.5mm DIA ZIMMER HUB
DE SOUTTER MEDICAL LIMITED
77262
Not in Commercial Distribution

  • 05051471021631 ()
77262

  • Cast cutter blade
SAGITTAL BLADE - MICROAIRE (1200-005) 6.9 x 20 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-005
Not in Commercial Distribution

  • 15051471005744 ()
  • 05051471005747 ()
S72-005

  • Surgical saw blade, sagittal, single-use
VAC POWER SUPPLY MOUNTING KIT
DE SOUTTER MEDICAL LIMITED
6310
Not in Commercial Distribution

  • 05051471005198 ()
6310

  • Medical device storage mount
STERILE TRAY RING COVER SPECIFICATIONS
JOHNSON & JOHNSON SURGICAL VISION, INC.
OM271000
Not in Commercial Distribution

  • 15050474520704 ()
  • 05050474520707 ()
OM271000

  • Medical equipment drape, single-use
5 SECOND RECTAL THERMOMETER
DOREL JUVENILE GROUP, INC.
TH111
In Commercial Distribution

  • 00884392951825 ()


  • Intermittent electronic patient thermometer
CIRCUMCISION TRAY 1.1
MEDLINE INDUSTRIES, INC.
CIT6260A
In Commercial Distribution

  • 40653160994221 ()
  • 10653160994220 ()
CIT6260A

  • General surgical procedure kit, non-medicated, single-use
SST DIAMOND V XLONG BLADE HALL(R) STYLE HUB
Microaire Surgical Instruments LLC
516065
Not in Commercial Distribution

  • 00847399017161 ()

  • Width: 19.7 Millimeter
  • Length: 100 Millimeter
  • Cutting Thickness: 1.4 mm


  • Surgical saw blade, sagittal, single-use
SST DIAMOND V XLONG BLADE STRYKER(R) STYLE HUB
Microaire Surgical Instruments LLC
516061
Not in Commercial Distribution

  • 00847399017130 ()

  • Width: 19.7 Millimeter
  • Length: 100 Millimeter
  • Cutting Thickness: 1.4 mm


  • Surgical saw blade, sagittal, single-use
SST DIAMOND V BLADE HALL(R) STYLE HUB
Microaire Surgical Instruments LLC
516055
Not in Commercial Distribution

  • 00847399017116 ()

  • Width: 25.4 Millimeter
  • Length: 85 Millimeter
  • Cutting Thickness: 1.4 mm


  • Surgical saw blade, sagittal, single-use
MICRO SAGITTAL, STRAIGHT BLADE
Microaire Surgical Instruments LLC
505338
Not in Commercial Distribution

  • 00847399017017 ()

  • Width: 9.4 Millimeter
  • Length: 25.4 Millimeter
  • Cutting Thickness: 0.6 mm


  • Surgical saw blade, sagittal, single-use
MICRO SAGITTAL STRAIGHT BLADE
Microaire Surgical Instruments LLC
505333
Not in Commercial Distribution

  • 00847399016997 ()

  • Width: 14 Millimeter
  • Length: 41 Millimeter
  • Cutting Thickness: 0.6 mm


  • Surgical saw blade, sagittal, single-use
ORTHOPOWER RECIP. TAPERED BLADE
Microaire Surgical Instruments LLC
277325
Not in Commercial Distribution

  • 00847399016973 ()

  • Width: 11.2 Millimeter
  • Length: 77.7 Millimeter
  • Cutting Thickness: 1 mm


  • Surgical saw blade, reciprocating, single-use
INSTRUMENT CABLE, FOR BATTERY INSTRUMENTS
Microaire Surgical Instruments LLC
7007-000
Not in Commercial Distribution

  • 00847399004512 ()


  • Orthopaedic implant-instrument extension adaptor, reusable
INSTRUMENT CABLE, PAL-600E TO 1025/1020
Microaire Surgical Instruments LLC
1006-PALE
Not in Commercial Distribution

  • 00847399000767 ()


  • Electrical-only medical device connection cable, reusable
Light Based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Bare+
Not in Commercial Distribution

  • 05060352784145 ()
  • 05060352783964 ()


  • Home-use intense pulsed light hair removal unit
Light based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Pure
Not in Commercial Distribution

  • 05060352782837 ()
  • 05060352782608 ()


  • Home-use intense pulsed light hair removal unit
Abena Pants Special M-L2, Premium holds 57 fluid ounces/1700 ml, for individuals with waist and hip measurements of 31-53".
Abena North America, Inc
1999905376
In Commercial Distribution

  • 05703538458613 ()
  • 05703538458477 ()


  • Adult nappy
Abena Slip Flexi Fit L-XL3, Premium holds 108 fluid ounces/3200ml for individuals with waist and hip measurements from 43-67"
Abena North America, Inc
1000020865
In Commercial Distribution

  • 05703538446160 ()
  • 05703538446177 ()


  • Adult nappy
Abena Slip Flexi Fit Premium, L-XL1 holds 78 fluid ounces/2300ml, for individuals with waist and hip measurements for 43-67".
Abena North America, Inc
1000020863
In Commercial Distribution

  • 05703538446139 ()
  • 05703538446122 ()


  • Adult nappy
Abena Slip Flex Fit M-L2, Premium holds 81 fluid ounces/2400 ml, for individuals with waist and hip measurements from 28-47"
Abena North America, Inc
1000020860
In Commercial Distribution

  • 05703538446078 ()
  • 05703538446061 ()


  • Adult nappy
Abena Slip Flexi Fit M-L1, Premium holds 61 fluid ounces/1800 ml, for individuals with waist and hip measurements from 28-47"
Abena North America, Inc
1000020859
In Commercial Distribution

  • 05703538446054 ()
  • 05703538446047 ()


  • Adult nappy
Abena Light Pads Super 4 Adult Incontinence holds 29 fluid ounces/850 ml which measures 7" x 17".
Abena North America, Inc
17160
In Commercial Distribution

  • 05703538382215 ()
  • 05703538382208 ()
  • 05703538445491 ()


  • Incontinence pants, single-use
Maternity Super Pads which measures 14.2 x 4.3 x 5.9".
Abena North America, Inc
16571
In Commercial Distribution

  • 05703538337444 ()
  • 05703538337437 ()
  • 05703538447600 ()


  • Incontinence pants, single-use
The Promaxo Fiducial Coil with Arm Mount is a 1-channel, receive-only coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
7181
Not in Commercial Distribution

  • 00850042098042 ()
7181

  • MRI system coil, radio-frequency
The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
6761-M
Not in Commercial Distribution

  • 00850042098035 ()
6761-M

  • MRI system coil, radio-frequency
The Promaxo Large Receive Coil Model 6761-L is a 5-channel, receive-only phased array coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Promaxo, Inc.
6761-L
Not in Commercial Distribution

  • 00850042098028 ()
6761-L

  • MRI system coil, radio-frequency
No Description
NORTH AMERICAN RESCUE, LLC
85-3889
Not in Commercial Distribution

  • 00842209123810 ()
85-3889

  • First aid kit, non-medicated, single-use
No Description
NORTH AMERICAN RESCUE, LLC
85-3823
Not in Commercial Distribution

  • 00842209122806 ()


  • First aid kit, non-medicated, single-use
No Description
INTERSCOPE, INC
ER 10-01-OP-S
Not in Commercial Distribution

  • 00854172008063 ()
ER 10-01-OP-S

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ER 10-03-F-S
Not in Commercial Distribution

  • 00854172008056 ()
ER 10-03-F-S

  • Tissue morcellation system handpiece, line-powered
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