Identity
- Trade Name
- Catasyn (3oz) FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin. Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns. FDA UDI
- Model / Reference
- 3 oz FDA UDI
- Description
- Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin. Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852181005332 FDA UDI
- 510(k) Number
- K172338 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-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
Yes
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 — 3 Fluid Ounce FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
Catasyn (3oz) by Synedgen, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wound hydrogel dressing, non-antimicrobial.
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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
- Synedgen, Inc.
Sources (1)
- FDA UDI c7737a1c-ab23-4006-9bb4-94ecab7012ee 36 fields · synced May 30, 2026