Primary Device ID | 00840194427975 |
NIH Device Record Key | 1b675921-1003-47e2-bcd5-c9e4022e4792 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Naviagtion Instrumentation |
Version Model Number | 01-1800-3003 |
Catalog Number | 01-1800-3003 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
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 | true |
Serial Number | false |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00840194427975 [Primary] |
OLO | Orthopedic stereotaxic instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
[00840194427975]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-07-02 |
Device Publish Date | 2022-12-15 |
00840194427951 | 4.0mm Nav Guide Window Tap |
00840194427999 | 5.5mm Nav Guide Window Tap |
00840194427982 | 4.5mm Nav Guide Window Tap |
00840194427975 | 6.0mm Nav Guide Window Tap |
00840194427968 | 5.0mm Nav Guide Window Tap |