Identity
- Trade Name
- PREMIER WRIST W/THUMB MD LT FDA UDI
- Generic Name
- Wrist immobilizer, single-use FDA UDI
- Model / Reference
- 90004553 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570119622 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Wrist immobilizer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Category: Wrist immobilizer, single-use
Premier Wrist W/Thumb Md Lt by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wrist immobilizer, single-use.
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- PRIMO WRIST W/THUMB BLK XS RT — BIRD & CRONIN, LLC · Class I
- PERFORMANCE WRIST MD LT — BIRD & CRONIN, LLC · Class I
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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
- Bird & Cronin, Llc
Sources (1)
- FDA UDI d2362af5-29fe-4cbe-a159-d656f205a9a0 32 fields · synced Jun 6, 2026