Identity
- Trade Name
- Shield Products FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- First aid wound FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- First aid wound FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851608007461 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Antimicrobial wound irrigation solution FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antimicrobial wound irrigation solution
Shield Products by Digital Ally, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ExSept Plus — Angelini Pharma Inc. · Class II
- BIAKOS™ Antimicrobial Skin & Wound Cleanser — Sanara Medtech Inc. · U
- Anasept Antimicrobial Skin and Wound Cleanser — Anacapa Technologies, Inc. · Class II
- Prontosan® — B. BRAUN MEDICAL INC. · 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 U | Pending data |
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Manufacturer
- Manufacturer
- Digital Ally, Inc.
Sources (1)
- FDA UDI a8bfd5b8-022a-4047-a572-05f9e53d605b 34 fields · synced Jun 8, 2026