Identity
- Trade Name
- PROCEED FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- PROCEED Surgical Mesh 15 cm x 15 cm (6" x 6") Sqare FDA UDI
- Model / Reference
- PCDM1 FDA UDI
- Description
- PROCEED Surgical Mesh 15 cm x 15 cm (6" x 6") Sqare FDA UDI
Identifiers
- Catalog Number
- PCDM1 FDA UDI
- Primary DI / UDI-DI
- 10705031047754 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
Similar devices
Also classified as Extra-gynaecological surgical mesh, composite-polymer.
- VENTRALIGHT — Davol Inc. · Class II
- VENTRALIGHT — Davol Inc. · Class II
- Symbotex — SOFRADIM PRODUCTION · Class II
- Ti-MESH — pfm medical titanium gmbh · Class II
- Parietex — SOFRADIM PRODUCTION · Class II
- Surgipro — Covidien LP · Class II
- Surgipro — Covidien LP · Class II
- Surgipro — Covidien LP · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Johnson & Johnson International Inc.
Sources (1)
- FDA UDI 879f0b8e-1a69-49f0-bbdf-6ae5bf6c8bd4 36 fields · synced Jun 8, 2026