| 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 |
| 00840194495158 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer |
| 00840194495165 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Dual Driver |
| 00840194495172 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Counter Torque Flag |
| 00840194495189 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Short Set Screw Driver |
| 00840194495196 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Counter Torque - Square Drive |
| 00840194495202 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Removal Tool |
| 00840194495219 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Tray 1 |
| 00840194495226 - Response 5.5/6.0 | 2026-01-08 5.5/6.0 Response Quick-Draw Reducer - Tray 2 |