AccessGUDID - DEVICE: INTERSTIM® (00613994925947)

GUDID

Device Identifier (DI) Information

Brand Name: INTERSTIM®
Version or Model: 305901
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994925947
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: LEAD 305901 PNE TEST STIM LEAD EMAN

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
QON	Implanted electrical device intended for treatment of fecal incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080025	083
P970004	187

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 -34 and 57 Degrees Celsius
Storage Environment Temperature: between -30 and 135 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a0b06583-be4f-41cb-bb04-a344ff98cad8
Public Version Date: December 23, 2022
Public Version Number: 4
DI Record Publish Date: August 25, 2015

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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