FDA UDI Not in Commercial Distribution 🇺🇸 United States

INTERSTIM®

DI: 20613994145066 · Model: 041831 · MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

Basic Information

Brand Name
INTERSTIM®
Primary DI
20613994145066
Version / Model
041831
Company Name
MEDTRONIC, INC.
Labeler DUNS
796986144
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2014-09-23
Public Version
4
Public Version Date
2023-07-12
Public Version Status
Update
Public Device Record Key
31d68eec-dfa2-44e7-9e2a-eb88cdd6ea34
Distribution End Date
2023-05-24

Device Description

CABLE 041831 INTERSTIM 6PK PAT SCNR

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 20613994145066
Unit of Use 00613994145062

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
P970004 000