Identity
- Trade Name
- PROCEED FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- PROCEED Surgical Mesh 20 cm x 25 cm (8" x 10") Oval FDA UDI
- Model / Reference
- PCDH1 FDA UDI
- Description
- PROCEED Surgical Mesh 20 cm x 25 cm (8" x 10") Oval FDA UDI
Identifiers
- Catalog Number
- PCDH1 FDA UDI
- Primary DI / UDI-DI
- 10705031047723 FDA UDI
- 510(k) Number
- K060713 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Extra-gynaecological surgical mesh, composite-polymer
Proceed by Johnson & Johnson International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K060713 also covers:
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
- PROCEED — Johnson & Johnson International Inc.
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
- Johnson & Johnson International Inc.
Sources (1)
- FDA UDI 044b3d8e-0de4-4999-9b4a-98aef4a206cc 36 fields · synced Jun 6, 2026