Identity
- Trade Name
- mBrace Wrist Support FDA UDI
- Generic Name
- Wrist immobilizer, single-use FDA UDI
- Device Name
- The mBrace Model 4200 is a wrist support device that extends the patient's wrist at a consistent 40° angle. FDA UDI
- Model / Reference
- 4200 FDA UDI
- Description
- The mBrace Model 4200 is a wrist support device that extends the patient's wrist at a consistent 40° angle. FDA UDI
Identifiers
- Catalog Number
- 140-0200-00 FDA UDI
- Primary DI / UDI-DI
- 10815614020125 FDA UDI
- FDA Product Code
- FMQ FDA UDI
- GMDN Term
- Wrist immobilizer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6760 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
Yes
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: Wrist immobilizer, single-use
mBrace Wrist Support by Semler Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Semler Technologies, Inc.
Sources (1)
- FDA UDI 919edef6-0cc3-491b-9324-a3fd4c9bc5c1 34 fields · synced Jun 7, 2026