Identity
- Trade Name
- PREMIER PLUS W/THUMB LG RT FDA UDI
- Generic Name
- Wrist immobilizer, single-use FDA UDI
- Model / Reference
- PC4661-RL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570131778 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
A portable, single-use wrist immobilizer designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure.
Similar devices
Also classified as Wrist immobilizer, single-use.
- mBrace Wrist Support with Clip — Semler Technologies, Inc. · Class I
- mBrace Wrist Support with Hook — Semler Technologies, Inc. · Class I
- Halyard — O&M HALYARD, INC. · Class I
- mBrace 4285 Wrist Support with Hook — Semler Technologies, Inc. · Class I
- PRIMO WRIST W/THUMB BLK XS RT — BIRD & CRONIN, LLC · Class I
- PERFORMANCE WRIST MD LT — BIRD & CRONIN, LLC · Class I
- MKO WRIST W/THUMB 10.5" RT LG — BIRD & CRONIN, LLC · Class I
- PREMIER WRIST W/THUMB LG LT — BIRD & CRONIN, LLC · 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 |
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Manufacturer
- Manufacturer
- Bird & Cronin, Llc
Sources (1)
- FDA UDI 437e5ae2-c741-4ec3-b07f-0da516da3656 32 fields · synced Jul 21, 2026