AccessGUDID - DEVICE: InterStim™ SureScan™ (00763000596958)

GUDID

Device Identifier (DI) Information

Brand Name: InterStim™ SureScan™
Version or Model: 978B133
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000596958
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44045	Sacral plexus implantable incontinence-control electrical stimulation system electrode	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QON	Implanted electrical device intended for treatment of fecal incontinence
EZW	Stimulator, electrical, implantable, for incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080025	223
P970004	328

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 33.0 Centimeter

Device Record Status

Public Device Record Key: 0a116301-4f05-43d9-a361-b894ab227d23
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: January 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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