Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Surgical internal adhesive/sealant, animal-derived FDA UDI
- Device Name
- Medical Hydrogel Dressing is applicable to partial thickness bumns, splitting skin donor sites wound, and epidermis defects resulted from other causes, venous leg ulcers, pressure ulcers and diabetic ulcers. FDA UDI
- Model / Reference
- SAS0403 FDA UDI
- Description
- Medical Hydrogel Dressing is applicable to partial thickness bumns, splitting skin donor sites wound, and epidermis defects resulted from other causes, venous leg ulcers, pressure ulcers and diabetic ulcers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971292003694 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Surgical internal adhesive/sealant, animal-derived FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical internal adhesive/sealant, animal-derived
Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical internal adhesive/sealant, animal-derived.
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- PreveLeak™ Surgical Sealant — Tenaxis Medical, Inc. · Class III
- PREVELEAK SURGICAL SEALANT — Baxter Healthcare Corp · Class III
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- TendoNova Ocelot — TendoNova Corporation · U
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 I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yuwen E-Commerce Co., Ltd.
Sources (1)
- FDA UDI cdbf971f-5ec7-432b-94ce-7573d8ab4253 34 fields · synced May 29, 2026