FDA UDI
In Commercial Distribution
🇺🇸 United States
Bodymate
DI: 06973712280029
·
Model: M
·
Hengshui Tianjian Medical Supplies CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bodymate
- Primary DI
- 06973712280029
- Version / Model
- M
- Company Name
- Hengshui Tianjian Medical Supplies CO.,LTD
- Labeler DUNS
- 529951803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-27
- Public Version
- 1
- Public Version Date
- 2024-04-04
- Public Version Status
- New
- Public Device Record Key
- 59495279-e5ea-450e-a874-14ed0dd7b86a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36228 | Hip orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or improve function of the hip; it is not dedicated to infants. It is typically adjustable and comprised of components that include a hip/pelvic girdle, thigh cuff, and articulated hip portion. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973712280029 | GS1 |