Identity
- Trade Name
- Armor Gel FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Device Name
- Armor Gel Wound Dressing Gel, .5 oz FDA UDI
- Model / Reference
- .5 oz FDA UDI
- Description
- Armor Gel Wound Dressing Gel, .5 oz FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851213004329 FDA UDI
- 510(k) Number
- K140483 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, antimicrobial FDA UDI
Classification
- Device Class
- U 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 14.17 Gram FDA UDI
Category: Wound hydrogel dressing, antimicrobial
Armor Gel by Abl Medical, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, antimicrobial.
- Pure&Clean — Pure & Clean, LLC · U
- EltaMD SilverGel 1.5 oz — CP Skin Health Group, Inc. · U
- BlastX™ — Next Science LLC · U
- Silver-sept Silver Antimicrobial Skin and Wound Gel — Anacapa Technologies, Inc. · U
- ProCure — Twin Med, LLC · U
- L-Mesitran Hydro — Theo Manufacturing B.V. · U
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
- Carestat — American Biotech Labs · U
Cleared under the same submission
K140483 also covers:
- ASAP OTC — Abl Medical, LLC
- ASAP OTC — Abl Medical, LLC
- ASAP OTC — Abl Medical, LLC
- Armor Gel — Abl Medical, LLC
- Armor Gel — Abl Medical, LLC
- Armor Gel — Abl Medical, LLC
- Armor Gel Canadian — Abl Medical, LLC
- Super Natural Silver — International Export Partners LLC
- Super Natural Silver — International Export Partners LLC
- Silverband — NSBT (Nano Silver Biotech Medical) Ltd.
- BE SMART GET PREPARED — TOTAL RESOURCES INTERNATIONAL INC.
- SILVEX — TOTAL RESOURCES 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 U | Pending data |
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Manufacturer
- Manufacturer
- Abl Medical, LLC
Sources (1)
- FDA UDI 8c6c772d-c582-4748-838b-9ca9bb43948e 36 fields · synced May 30, 2026