Inliant 9000101
GUDID 00850049386111
Inliant System, US, Full Package
Navigate Surgical Technologies Inc
Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system| Primary Device ID | 00850049386111 |
| NIH Device Record Key | 8d0021f3-bf28-4ddb-aec2-6f08b2e09687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inliant |
| Version Model Number | 900010-1 |
| Catalog Number | 9000101 |
| Company DUNS | 204920011 |
| Company Name | Navigate Surgical Technologies Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850049386111 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213392
FDA Product Code
| PLV | Dental Stereotaxic Instrument |
| QRY | Dental Navigation System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2023-09-05 |
On-Brand Devices [Inliant]
| 00850049386111 | Inliant System, US, Full Package |
| 00850049386029 | Consumable - Fiducial Kit |
Trademark Results [Inliant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INLIANT 85963325 4905514 Live/Registered |
Navigate Surgical Technologies, Inc. 2013-06-18 |
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