FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tairuibosi
DI: 06974870090840
·
Model: TRB-497-#13
·
TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tairuibosi
- Primary DI
- 06974870090840
- Version / Model
- TRB-497-#13
- Company Name
- TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD.
- Labeler DUNS
- 729210247
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-08
- Public Version
- 1
- Public Version Date
- 2023-11-16
- Public Version Status
- New
- Public Device Record Key
- c20f8ffe-e24a-48fa-8f4f-643508d5180e
- Distribution End Date
- 2023-11-08
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
- No
- 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 |
|---|---|---|---|---|
| KNP | Orthosis, Corrective Shoe | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31041 | Orthotic shoe, non-customized | A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974870090840 | GS1 |