FDA UDI
In Commercial Distribution
🇺🇸 United States
ELITE BRITE
DI: 06973712280104
·
Model: XL
·
Hengshui Tianjian Medical Supplies CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELITE BRITE
- Primary DI
- 06973712280104
- Version / Model
- XL
- 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
- 2024-06-03
- Public Version
- 1
- Public Version Date
- 2024-06-11
- Public Version Status
- New
- Public Device Record Key
- 89c15588-18dc-40da-a15c-57e80726cf5c
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
- No
- 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 |
|---|---|---|---|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64290 | Adhesive lumbar support | A device intended to be externally adhered to the lower back for support to assist with posture improvement and/or to help relieve low back pain. It consists of a preformed shape of orthopaedic adhesive tape with a stiff internal strut typically of made of polymer materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973712280104 | GS1 |