FDA UDI
In Commercial Distribution
🇺🇸 United States
Trulife
DI: 00645517857589
·
Model: T39S-02
·
TRULIFE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trulife
- Primary DI
- 00645517857589
- Version / Model
- T39S-02
- Company Name
- TRULIFE LIMITED
- Labeler DUNS
- 289728891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-31
- Public Version
- 2
- Public Version Date
- 2023-06-08
- Public Version Status
- Update
- Public Device Record Key
- 199b36be-94b5-4c39-9f74-f10e88eb995b
Device Description
ARTICULATING HYPEREXTENSION BRACE SM-MD SHORT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- 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 |
|---|---|---|---|---|
| MRI | ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41042 | Thoracic spine orthosis | A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00645517857589 | GS1 |