Primary Device ID | 00817421021787 |
NIH Device Record Key | 7c9cb588-ac9b-49a7-a561-60a410dbb3a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | X-Guide |
Version Model Number | P011000 |
Company DUNS | 026096247 |
Company Name | XNAV TECHNOLOGIES LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | true |
OTC Over-The-Counter | false |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com | |
Phone | 267-436-0414 |
kimberly.chan@x-navtech.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817421021787 [Primary] |
PLV | Dental Stereotaxic Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-13 |
Device Publish Date | 2021-09-03 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
X-GUIDE 85925057 4896013 Live/Registered |
X-Nav Technologies, LLC 2013-05-07 |