| Primary Device ID | 00840194418300 |
| NIH Device Record Key | 4c58bb56-14bc-4b33-bdc5-086f66e780ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Response 4.5/5.0 |
| Version Model Number | 03-1600-0100 |
| Catalog Number | 03-1600-0100 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840194418300 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
[00840194418300]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 00841132187166 | 5.0/5.5 TRANSITION ROD, TI ALLOY, 600MM |
| 00841132185414 | 5.0/6.0 TRANSITION ROD, COCR, 600MM |
| 00841132185407 | 5.0/5.5 TRANSITION ROD, COCR, 600MM |
| 00841132185391 | 4.5/6.0 TRANSITION ROD, COCR, 600MM |
| 00841132185384 | 4.5/5.5 TRANSITION ROD, COCR, 600MM |
| 00841132185377 | 5.0/6.0 TRANSITION ROD, TI ALLOY, 600MM |
| 00841132187227 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 100MM - DOUBLE LEAD |
| 00841132187210 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 90MM - DOUBLE LEAD |
| 00841132187203 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 80MM - DOUBLE LEAD |
| 00841132187197 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 100MM - DOUBLE LEAD |
| 00841132187180 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 90MM - DOUBLE LEAD |
| 00841132187173 | 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 80MM - DOUBLE LEAD |
| 00840194418454 | SI Fixation Lid |
| 00840194418447 | 4.5/5.0 SI Fixation Implant Caddy |
| 00840194418300 | 4.5/5.0 SI Fixation Caddy |