FDA UDI
In Commercial Distribution
🇺🇸 United States
InterStim™
DI: 00763000295547
·
Model: 309201
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InterStim™
- Primary DI
- 00763000295547
- Version / Model
- 309201
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 2
- Public Version Date
- 2026-01-22
- Public Version Status
- Update
- Public Device Record Key
- 79d810a6-e100-4e0e-bb56-aee665f77966
Device Description
LEAD 309201 ISTIM TEST STIM EMAN LF45
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| QON | Implanted electrical device intended for treatment of fecal incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000295547 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080025 | 221 |
| P970004 | 326 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12.0 | Inch | |
| Length | 30.5 | Centimeter |