FDA UDI
In Commercial Distribution
🇺🇸 United States
Trek
DI: 00801741201356
·
Model: TKDRIVER
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trek
- Primary DI
- 00801741201356
- Version / Model
- TKDRIVER
- Catalog Number
- TKDRIVER
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-28
- Public Version
- 1
- Public Version Date
- 2022-05-06
- Public Version Status
- New
- Public Device Record Key
- ad393336-7964-491e-a769-b7bf81e81a6d
Device Description
Trek™ Power Driver
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62076 | Intraosseous-access handpiece, biopsy | A hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for bone lesion biopsy and/or bone marrow biopsy; it may also be intended for aspiration. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741201356 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]