Identity
- Trade Name
- Advanced Shield Chronic Wound Care, 2oz FDA UDI
- Generic Name
- Skin semi-occlusive dressing, antimicrobial FDA UDI
- Device Name
- Topical burn and wound dressing, hydrogel barrier antimicrobial with silver,2oz spray HCPCS code A6248 FDA UDI
- Model / Reference
- 6011220 FDA UDI
- Description
- Topical burn and wound dressing, hydrogel barrier antimicrobial with silver,2oz spray HCPCS code A6248 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858071004317 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Skin semi-occlusive dressing, antimicrobial 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Skin semi-occlusive dressing, antimicrobial
Advanced Shield Chronic Wound Care, 2oz by Kericure Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin semi-occlusive dressing, antimicrobial.
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- ViveCare — VIVE HEALTH LLC · Class I
- ViveCare — VIVE HEALTH LLC · U
- Troubless — FARMSKIN Inc. · Class I
- Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz Tube — Kericure Inc. · Class I
- Advanced Shield Max Silver Barrier, .5oz spray — Kericure Inc. · Class I
- Advanced Shield Max Silver Barrier, 1oz spray — Kericure Inc. · Class I
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
- Kericure Inc.
Sources (1)
- FDA UDI 52bb7857-eeae-4376-aceb-68a300ddb2c6 33 fields · synced Jun 1, 2026