Identity
- Trade Name
- ADD-A-SPLINT™ - HALF ARM FDA UDI
- Generic Name
- First aid limb splint, mouldable, reusable FDA UDI
- Model / Reference
- AD-102 FDA UDI
Identifiers
- Catalog Number
- AD-102 FDA UDI
- Primary DI / UDI-DI
- 00609271483033 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- First aid limb splint, mouldable, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: First aid limb splint, mouldable, reusable
Add-A-Splint™ - Half Arm by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid limb splint, mouldable, reusable.
- Spencer — SPENCER ITALIA SRL · Class I
- SAM Splint — SAM Medical Products · Class I
- Dynarex ActiSplint — Dynarex Corp. · Class I
- SAM Splint — SAM Medical Products · Class I
- SAM Splint — SAM Medical Products · Class I
- SAM Soft Shell Splint — SAM Medical Products · Class I
- SAM Splint — SAM Medical Products · Class I
- SAM Splint — SAM Medical Products · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI 62bc294d-6bfe-4361-b047-e1f07eafd8fe 33 fields · synced Jun 9, 2026