Primary Device ID | 00840194427951 |
NIH Device Record Key | c1c511d6-fee1-4076-b197-11f6f0eb3625 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Naviagtion Instrumentation |
Version Model Number | 01-1800-3001 |
Catalog Number | 01-1800-3001 |
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 |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com | |
Phone | +1(574)268-6379 |
xxx@xxx.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840194427951 [Primary] |
OLO | Orthopedic stereotaxic instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
[00840194427951]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-03-20 |
Device Publish Date | 2022-12-15 |
00840194418003 - 3P Hip System | 2025-06-30 3P 5.0mm Non-Locking Screw Tap |
00840194493925 - 3P Hip System | 2025-06-30 3P 3.5mm XL Non-Locking Screw Tap |
00840194493949 - 3P Hip System | 2025-06-30 3P 5.0mm XL Non-Locking Screw Tap |
00841132185896 - 3P Hip System | 2025-06-30 3P 3.5mm Non-Locking Screw Tap |
00841132186497 - 3P Hip System | 2025-06-30 3P 3.5mm Locking Screw Tap |
00841132186633 - 3P Hip System | 2025-06-30 3P 5.0mm Locking Screw Tap |
00840194418096 - 3P Hip System | 2025-06-27 3P Child Beam - Trauma Barrel Reamer |
00840194418102 - 3P Hip System | 2025-06-27 3P Adolescent Beam - Trauma Barrel Reamer |