AccessGUDID - DEVICE: INTERSTIM (00613994141996)

GUDID

Device Identifier (DI) Information

Brand Name: INTERSTIM
Version or Model: 3065USC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994141996
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: PNE Kit, 3065USC, InterStim, US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
61394	Sacral plexus percutaneous incontinence-control electrical stimulation system electrode	A sterile wire, insulated with non-conductive material except at its electrode(s), intended to be percutaneously introduced short-term (<=30 days) to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, by making to make an electrical connection between an external electrical stimulation system pulse generator and the sacral plexus. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZW	Stimulator, electrical, implantable, for incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970004	000

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
Storage Environment Temperature: between -30 and 135 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 41.0 Centimeter
Length: 16.0 Inch

Device Record Status

Public Device Record Key: b13f96fa-36ce-4039-a75f-55a612d65b78
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2014