FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviNetics Skull Anchor Extended Screw Kit
DI: 10850023620207
·
Model: NN1700
·
Navinetics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- NaviNetics Skull Anchor Extended Screw Kit
- Primary DI
- 10850023620207
- Version / Model
- NN1700
- Catalog Number
- NN1700
- Company Name
- Navinetics, Inc.
- Labeler DUNS
- 838320260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-07-24
- Public Version
- 1
- Public Version Date
- 2023-08-01
- Public Version Status
- New
- Public Device Record Key
- 61b94ec1-b3a9-4ea0-a90d-efd47955dbe2
Device Characteristics
- Single Use
- Yes
- 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 Conditional
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850023620207 | GS1 | ||||
| Unit of Use | 10850023620221 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231392 | 000 |