Identity
- Trade Name
- Kay Kare FDA UDI
- Generic Name
- First aid limb splint, mouldable, single-use FDA UDI
- Device Name
- Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Splint. FDA UDI
- Model / Reference
- 10-30105 DS FDA UDI
- Description
- Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Splint. FDA UDI
Identifiers
- Catalog Number
- 10-30105 DS FDA UDI
- Primary DI / UDI-DI
- 00818634020017 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- First aid limb splint, mouldable, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Kay Kare by Bosma Enterprises — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bosma Enterprises
Sources (1)
- FDA UDI 77c85bf0-1fe2-4581-9ec9-ce4cbe0d9231 37 fields · synced May 30, 2026