Identity
- Trade Name
- 18M - Burn Relief FDA UDI
- Generic Name
- Burn kit, medicated FDA UDI
- Device Name
- 18M - Burn Relief FDA UDI
- Model / Reference
- K203-031 FDA UDI
- Description
- 18M - Burn Relief FDA UDI
Identifiers
- Catalog Number
- K203-031 FDA UDI
- Primary DI / UDI-DI
- 00766588030319 FDA UDI
- 510(k) Number
- K941311 FDA UDI
- FDA Product Code
- LRR FDA UDI
- GMDN Term
- Burn kit, medicated FDA UDI
Classification
- Device Class
- N 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Burn kit, medicated
18M - Burn Relief by Certified Safety Manufacturing, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Burn kit, medicated.
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 N | Pending data |
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Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 2e7e8afc-44c6-47aa-b5da-a3ccd2e59ed9 36 fields · synced May 30, 2026