Identity
- Trade Name
- Zenapro FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
- Device Name
- Zenapro Hybrid Hernia Repair Device FDA UDI
- Model / Reference
- G35114 FDA UDI
- Description
- Zenapro Hybrid Hernia Repair Device FDA UDI
Identifiers
- Catalog Number
- C-HYB-30X30 FDA UDI
- Primary DI / UDI-DI
- 10827002351148 FDA UDI
- 510(k) Number
- K111695 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Zenapro by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 4a61a8d4-1539-454c-8837-4d93fc152b2c 38 fields · synced Jun 8, 2026