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Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE bottles with Trigger sprayer FDA UDI
- Model / Reference
- 4012SC FDA UDI
- Description
- Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE bottles with Trigger sprayer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856040008434 FDA UDI
- 510(k) Number
- K073547 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Category: Antimicrobial wound irrigation solution
Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE by Argentum Medical, Llc — Class U — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Antimicrobial wound irrigation solution.
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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
- 3% NaOCL Sodium Hypochlorite — Vista Dental · U
Cleared under the same submission
K073547 also covers:
- Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bottles with — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with d — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with f — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. PET bottles with d — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. PET bottles with f — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bot — ARGENTUM MEDICAL, LLC
- Anasept Antimicrobial Wound Irrigation Solution filled in 16 oz. PET bottles wit — ARGENTUM MEDICAL, LLC
- Spanish - Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top — ARGENTUM MEDICAL, LLC
- Spanish-Anasept Antimicrobial Skin and Wound cleanser filled in 15 oz. HDPE bott — ARGENTUM MEDICAL, LLC
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
- Argentum Medical, Llc
Sources (1)
- FDA UDI 1c94152e-75e9-4880-9881-decaf10e5124 34 fields · synced May 30, 2026