Identity
- Trade Name
- Surgipro FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- Mesh Hernia Plug and Patch FDA UDI
- Model / Reference
- SMPM-02 FDA UDI
- Description
- Mesh Hernia Plug and Patch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521101302 FDA UDI
- 510(k) Number
- K982575 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extra-gynaecological surgical mesh, composite-polymer
Surgipro by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, composite-polymer.
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- Parietex — SOFRADIM PRODUCTION · Class II
- GORE SYNECOR Biomaterial — W. L. GORE & ASSOCIATES, INC · Class II
- PROCEED — Johnson & Johnson International Inc. · Class II
Cleared under the same submission
K982575 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI bd4841f0-40b0-4a2f-ac35-f70fe3a50e57 36 fields · synced Jun 8, 2026