FDA UDI
In Commercial Distribution
🇺🇸 United States
mBrace Wrist Support with Clip
DI: 10815614020163
·
Model: 4275
·
Semler Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- mBrace Wrist Support with Clip
- Primary DI
- 10815614020163
- Version / Model
- 4275
- Catalog Number
- 140-0275-00
- Company Name
- Semler Technologies, Inc.
- Labeler DUNS
- 042075700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 4
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 38c3f993-b46e-40c8-9ec2-cabfdc9398f1
Device Description
The mBrace Model 4275 is a wrist support device that extends the patient's wrist at a consistent 40°angle with a syringe clip to attach a syringe.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMQ | Restraint, Protective | General Hospital | 880.6760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45128 | Wrist splint, single-use | A rigid external support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815614020160 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 10815614020163 | GS1 |