FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfyhealth
DI: 04719879646603
·
Model: TP34
·
Comfy Health Group Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comfyhealth
- Primary DI
- 04719879646603
- Version / Model
- TP34
- Company Name
- Comfy Health Group Co., Ltd.
- Labeler DUNS
- 658202517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-08
- Public Version
- 1
- Public Version Date
- 2025-12-16
- Public Version Status
- New
- Public Device Record Key
- 3fb8d711-f104-4893-b1a2-d33bce4def77
Device Description
BRACOO TP34 Thumb Fulcrum Wrap Ergonomic Splint Black Free size
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISR | Band Or Belt, Pelvic Support | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41459 | Wrist/hand orthosis | An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719879646603 | GS1 |