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
HAW Neurological Stereotaxic Instrument

GMDN Terms

Code Name
32568 Neurological stereotactic surgery system

Identifiers

Type ID
Primary 10850023620207
Unit of Use 10850023620221

Premarket Submissions

Submission Number Supplement Number
K231392 000