FDA UDI
In Commercial Distribution
🇺🇸 United States
Traction Pin Kit
DI: M791TPK12180
·
Model: TPK1218
·
BIOACCESS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Traction Pin Kit
- Primary DI
- M791TPK12180
- Version / Model
- TPK1218
- Company Name
- BIOACCESS INC
- Labeler DUNS
- 942203001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- a202bb01-b9c4-44a8-968f-5ce62c84caa3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44053 | Orthopaedic surgical procedure kit, medicated | A collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M791TPK12180 | HIBCC |