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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4-ply mask
Abena North America, Inc
1000020586
Not in Commercial Distribution

  • 00810049810207 ()
  • 00810049810191 ()


  • Public face mask, single-use
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO Universal 2.0 packed kit for BirdandBe - 2 tests
In Commercial Distribution

  • 07290016650587 ()
YO-FA-01912-00

  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
Dongguan City Umed Technology Co., Ltd
MD-206
Not in Commercial Distribution

  • 16975977230013 ()
  • 06975977230016 ()


  • Eyelid massager
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
MNA-240 DEC V2 AT
Barco NV
MNA-240
Not in Commercial Distribution

  • 05415334001626 ()
K9303271A

  • Operating room audiovisual data/device management system
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
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
No Description
INTERSCOPE, INC
ER 10-03-OP
Not in Commercial Distribution

  • 00854172008032 ()
ER 10-03-OP

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ER 10-02-O
Not in Commercial Distribution

  • 00854172008018 ()
ER 10-02-O

  • Tissue morcellation system handpiece, line-powered
No Description
INTERSCOPE, INC
ER 10-01-OP
Not in Commercial Distribution

  • 00854172008001 ()
ER 10-01-OP

  • Tissue morcellation system handpiece, line-powered
SAW HANGER BRACKET - CC5/6
DE SOUTTER MEDICAL LIMITED
7670
Not in Commercial Distribution

  • 05051471032316 ()
7670

  • Medical device storage mount
HST BUR
DE SOUTTER MEDICAL LIMITED
H51-0520
Not in Commercial Distribution

  • 15051471089843 ()
  • 05051471089846 ()
H51-0520

  • Orthopaedic bur, single-use
HST BUR
DE SOUTTER MEDICAL LIMITED
H50-0520
Not in Commercial Distribution

  • 15051471089768 ()
  • 05051471089761 ()
H50-0520

  • Orthopaedic bur, single-use
SAGITTAL BLADE - MICROAIRE (1200-009) 10.2 x 18 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-009
Not in Commercial Distribution

  • 15051471025292 ()
  • 05051471025295 ()
S72-009

  • Surgical saw blade, sagittal, single-use
SAGITTAL BLADE - MICROAIRE (1200-007) 4.3 x 15 x 0.50mm
DE SOUTTER MEDICAL LIMITED
S72-007
Not in Commercial Distribution

  • 15051471025254 ()
  • 05051471025257 ()
S72-007

  • Surgical saw blade, sagittal, single-use
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
Abena Slip Flexi Fit L-XL4, Premium holds 128 fluid ounces/3800 ml, for individuals with hip and waist measurements of 43-67".
Abena North America, Inc
1000021167
In Commercial Distribution

  • 57135710001592 ()
  • 05713571001585 ()


  • Adult nappy
Abena Slip Flexi Fit M-L4, Premium holds 115 fluid ounces/3400ml, for individuals with hip and waist measurements from 28-47"
Abena North America, Inc
1000021166
In Commercial Distribution

  • 05713571001578 ()
  • 05713571001561 ()


  • Adult nappy
Abena Pants XL3, Premium holds 88 fluid ounces/2600 ml, for individuals for waist and hip measurements of 51-67". Generally it is classified as a XL size.
Abena North America, Inc
1000021330
In Commercial Distribution

  • 05713571001035 ()
  • 05713571001028 ()


  • Adult nappy
Abena Pants XL2, Premium holds 64 fluid ounces/1900 ml, for individuals for waist and hip measurements of 51-67". Generally it is classified as a XL size.
Abena North America, Inc
1000021329
In Commercial Distribution

  • 05713571001011 ()
  • 05713571001004 ()


  • Adult nappy
Abena Pants XL1, Premium holds 47 fluid ounces/1400 ml, for individuals for waist and hip measurements of 51-67".
Abena North America, Inc
1000021328
In Commercial Distribution

  • 05713571000991 ()
  • 05713571000984 ()


  • Adult nappy
Abena Pants L3, Premium holds 81 fluid ounces/2400 ml, for individuals for waist and hip measurements of 39-55". Generally it is classified as a L size.
Abena North America, Inc
1000021327
In Commercial Distribution

  • 05713571000977 ()
  • 05713571000960 ()


  • Adult nappy
Abena Pants L2, Premium holds 64 fluid ounces/1900 ml, for individuals for waist and hip measurements of 39-55". Generally it is classified as a L size.
Abena North America, Inc
1000021326
In Commercial Distribution

  • 05713571000953 ()
  • 05713571000946 ()


  • Adult nappy
Abena Pants L1, Premium holds 47 fluid ounces/1400 ml, for individuals for waist and hip measurements of 39-55". Generally it is classified as a L size.
Abena North America, Inc
1000021325
In Commercial Distribution

  • 05713571000939 ()
  • 05713571000922 ()


  • Adult nappy
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