Primary Device ID | 00841132124277 |
NIH Device Record Key | 4b4c536c-07c8-43c9-afcf-c431b689994c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACL |
Version Model Number | 01-1008-2530 |
Catalog Number | 01-1008-2530 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 | 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 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132124277 [Primary] |
FZH | Apparatus, air handling, room |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
[00841132124277]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-14 |
Device Publish Date | 2021-07-06 |
00840194493871 - Playbook | 2024-08-27 Playbook Software |
00840194493765 - Playbook | 2024-08-19 Assembled Playbook Unit |
00840194478410 - Broken Screw Removal Instruments | 2024-08-15 1.5mm Easy Out |
00840194478427 - Broken Screw Removal Instruments | 2024-08-15 2.0mm Easy Out |
00840194478434 - Broken Screw Removal Instruments | 2024-08-15 2.5mm Easy Out |
00840194478441 - Broken Screw Removal Instruments | 2024-08-15 3.0mm Easy Out |
00840194478458 - Broken Screw Removal Instruments | 2024-08-15 3.5mm Easy Out |
00840194478465 - Broken Screw Removal Instruments | 2024-08-15 4.0mm Easy Out |