Identity
- Trade Name
- NEOVEIL FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6. FDA UDI
- Model / Reference
- NV-ET-M60E-3 FDA UDI
- Description
- NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6. FDA UDI
Identifiers
- Catalog Number
- NV-ET-M60E-3 FDA UDI
- Primary DI / UDI-DI
- 04973077713776 FDA UDI
- 510(k) Number
- K221487 FDA UDI
- FDA Product Code
- OXC FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable 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
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDIWidth — 17 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Neoveil by Gunze Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.
- PDS Plates — Ethicon Inc. · Class II
- Vivosorb — Polyganics Innovations B.V. · Class II
- Ballast — ISOTIS ORTHOBIOLOGICS, INC · Class II
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforce — W. L. GORE & ASSOCIATES, INC · Class II
- GalaFLEX 3D — Tepha, Inc. · Class II
- TIGR® Matrix Surgical Mesh — Novus Scientific AB · Class II
- Phasix — Davol Inc. · Class II
- GalaFLEX LITE — Tepha, Inc. · Class II
Cleared under the same submission
K221487 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
- Gunze Limited
Sources (1)
- FDA UDI a20c82dc-53aa-4645-924e-6be68dcdcf61 37 fields · synced Jun 8, 2026