Identity
- Trade Name
- Silverstream OTC FDA UDI
- Generic Name
- Antimicrobial wound irrigation solution FDA UDI
- Device Name
- SilverStream OTC 250ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level. FDA UDI
- Model / Reference
- SS-1000-01 FDA UDI
- Description
- SilverStream OTC 250ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level. FDA UDI
Identifiers
- Catalog Number
- FBS-01-1-OSS-1000-01 FDA UDI
- Primary DI / UDI-DI
- 07290019690108 FDA UDI
- 510(k) Number
- K093227 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
Yes
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
- Total Volume — 250 Milliliter FDA UDI
Category: Antimicrobial wound irrigation solution
Silverstream OTC by SilverStream Medical Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antimicrobial wound irrigation solution.
- Puracyn® Plus Professional Formula — Innovacyn, Inc. · U
- Anasept Antimicrobial Skin and Wound cleanser filled in 12oz. Boston round, HDPE — ARGENTUM MEDICAL, LLC · U
- Anasept Antimicrobial Skin and Wound cleanser filled in 4 oz. PET bottles with f — ARGENTUM MEDICAL, LLC · U
- ELECTROCYN soma — V3Bio Sdn. Bhd · U
- Shield Products — Digital Ally, Inc. · U
- 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
Cleared under the same submission
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
- SilverStream Medical Ltd.
Sources (1)
- FDA UDI 4ee6b744-92be-4fbf-b2f2-578adc27b336 38 fields · synced May 30, 2026