FDA UDI
In Commercial Distribution
🇺🇸 United States
Cranial Drill Bit,5 pack
DI: 07290109180625
·
Model: KIT0722-01
·
MAZOR ROBOTICS LTD
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cranial Drill Bit,5 pack
- Primary DI
- 07290109180625
- Version / Model
- KIT0722-01
- Company Name
- MAZOR ROBOTICS LTD
- Labeler DUNS
- 532681590
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-26
- Public Version
- 4
- Public Version Date
- 2024-02-15
- Public Version Status
- Update
- Public Device Record Key
- e8be0b3a-e32f-47ad-a09a-8b910aa2a509
Device Description
Cranial Drill Bit,5 pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45416 | Muscle biopsy clamp | A sterile manual gripping device designed to secure muscle tissue in order to obtain a biopsy sample. It is used to hold a muscle fibre specimen in a longitudinal position to help preserve the original orientation of the fibres, from the sampling stage through analysis of the tissue. It will typically be designed so that, with the in situ sample, it can fit into an automated histological processing/analysing machine. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109180625 | GS1 |