X-Guide P010306
GUDID 00817421021404
BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
Surgical planning/navigation-enhancement system| Primary Device ID | 00817421021404 |
| NIH Device Record Key | 86c33f91-3a15-4b30-8958-6ea6b856620a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Guide |
| Version Model Number | P010306 |
| Catalog Number | P010306 |
| Company DUNS | 026096247 |
| Company Name | XNAV TECHNOLOGIES LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817421021398 [Primary] |
| GS1 | 00817421021404 [Package] Contains: 00817421021398 Package: Pouch [2 Units] In Commercial Distribution |
| GS1 | 00817421022715 [Package] Contains: 00817421021398 Package: Pouch [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150222
FDA Product Code
| PLV | Dental Stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
[00817421021404]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-02 |
| Device Publish Date | 2021-01-25 |
On-Brand Devices [X-Guide]
| 00817421020797 | X-Guide System Software Version 2.3.0 |
| 00817421020735 | CALIBRATION DISC ASM - FRICTION GRIP |
| 00817421020728 | HANDPIECE CONNECTOR ASM. - BIEN AIR |
| 00817421020711 | COMPUTER MOUSE |
| 00817421020599 | KEYBOARD |
| 00817421020575 | OFFSET TRACKER ARM - RIGHT |
| 00817421020568 | OFFSET TRACKER ARM - LEFT |
| 00817421020520 | X-CLIP |
| 00817421020513 | BASELINE CALIBRATION PLATE |
| 00817421020506 | SAFETY GLASSES |
| 00817421020490 | HANDPIECE CONNECTOR ASM. - W&H |
| 00817421020483 | HANDPIECE CONNECTOR ASM. - NOUVAG |
| 00817421020476 | HANDPIECE ASSEMBLY TOOL |
| 00817421020452 | BONE SCREW - 2.7Ø x 10mm |
| 00817421020438 | BONE SCREW - 2.7Ø x 8mm |
| 00817421020414 | BONE SCREW - 2.7Ø x 6mm |
| 00817421020391 | BONE SCREW - 2.7Ø x 4mm |
| 00817421020377 | BONE SCREW - 2.0Ø x 10mm |
| 00817421020353 | BONE SCREW - 2.0Ø x 8mm |
| 00817421020339 | BONE SCREW - 2.0Ø x 6mm |
| 00817421020315 | BONE SCREW - 2.0Ø x 4mm |
| 00817421020292 | EDENTULOUS CLIP - NO SPIKES |
| 00817421020278 | EDENTULOUS CLIP |
| 00817421020261 | EDENTULOUS KIT |
| 00817421020254 | STRAIGHT HANDPIECE CALIBRATION BIT |
| 00817421020247 | WRENCH |
| 00817421020230 | PROBE TOOL |
| 00817421020223 | SCREW DRIVER |
| 00817421020216 | TRACKER ARM - LEFT |
| 00817421020209 | TRACKER ARM - RIGHT |
| 00817421020193 | TRACKER ARM - UNIVERSAL |
| 00817421020186 | HANDPIECE CALIBRATION DISC |
| 00817421020179 | GO PLATE |
| 00817421020162 | PATIENT TRACKER |
| 00817421020155 | PROBE TOOL TRACKER |
| 00817421020148 | HANDPIECE TRACKER |
| 00817421020131 | INSTRUMENT KIT |
| 00817421020124 | X-CLIP - PRACTICE |
| 00817421020117 | X-GUIDE TRAINING KIT |
| 00817421020100 | X-GUIDE USER MANUAL, ENGLISH |
| 00817421020063 | X-GUIDE REGION KIT - NORTH AMERICA, ENGLISH |
| 00817421020056 | CART TRAY KIT |
| 00817421020025 | X-GUIDE (United States) |
| 00817421020018 | X-GUIDE PLANNING SOFTWARE - MAC OS |
| 00817421020001 | X-GUIDE PLANNING SOFTWARE - MS WINDOWS |
| 00817421020988 | LOANER PRACTICE KIT |
| 00817421020971 | X-Guide 2.3.6 Linux Software |
| 00817421021183 | X-Guide 3.1.0 Linux Software |
| 00817421020964 | X-Guide 2.3.5 Linux Software |
| 00817421020896 | X-Guide 2.3.2 Linux Software |
Trademark Results [X-Guide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-GUIDE 85925057 4896013 Live/Registered |
X-Nav Technologies, LLC 2013-05-07 |
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