Identity
- Trade Name
- Puracyn® Plus Professional Formula FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Model / Reference
- 6549 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818582012782 FDA UDI
- 510(k) Number
- K150799 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
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
Dimensions & Sizes
- Size
- Total Volume — 237 Milliliter FDA UDI
Category: Wound hydrogel dressing, antimicrobial
Puracyn® Plus Professional Formula by Innovacyn, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, antimicrobial.
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- ProCure — Twin Med, LLC · U
- Armor Gel — Abl Medical, 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
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
- Innovacyn, Inc.
Sources (1)
- FDA UDI 9952df43-9b62-4182-a63f-962e4fbb3004 35 fields · synced May 29, 2026