Identity
- Trade Name
- InterStim™ Micro SureScan™ FDA UDI
- Generic Name
- Implantable incontinence-control electrical stimulation system pulse generator FDA UDI
- Device Name
- INS 97810 ISTM MICRO SSMRI RC EMAN US FDA UDI
- Model / Reference
- 97810 FDA UDI
- Description
- INS 97810 ISTM MICRO SSMRI RC EMAN US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000203849 FDA UDI
- FDA Product Code
- EZW FDA UDI
- GMDN Term
- Implantable incontinence-control electrical stimulation system pulse generator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 876.5270 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Implantable incontinence-control electrical stimulation system pulse generator
InterStim™ Micro SureScan™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P080025 also covers:
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P970004 also covers:
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
- INTERSTIM® — MEDTRONIC, INC.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 47fe6aea-3f17-475d-a299-d0df4720f998 35 fields · synced Jun 1, 2026