Identity
- Trade Name
- Roosin FDA UDI
- Generic Name
- Burn gel FDA UDI
- Device Name
- Relieve burn gel 100mmx100mm FDA UDI
- Model / Reference
- 100mmx100mm FDA UDI
- Description
- Relieve burn gel 100mmx100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16958868749009 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Burn gel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Burn gel
Roosin by Roosin Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
Sources (1)
- FDA UDI 4a5c06f2-040e-489f-84f7-da42337301ef 33 fields · synced May 30, 2026