FDA UDI
In Commercial Distribution
🇺🇸 United States
KIVA Gen 2 Bone Drill
DI: 00815212023644
·
Model: ACC5225
·
Izi Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KIVA Gen 2 Bone Drill
- Primary DI
- 00815212023644
- Version / Model
- ACC5225
- Company Name
- Izi Medical Products, LLC
- Labeler DUNS
- 933506164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-03
- Public Version
- 1
- Public Version Date
- 2020-06-11
- Public Version Status
- New
- Public Device Record Key
- 17175577-f355-41fe-b612-54398ff811f9
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11330 | Biopsy drill bit | A shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815212023644 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070293 | 000 |