| Primary Device ID | 00840194499200 |
| NIH Device Record Key | b4c22eb1-f2d3-43f9-9a7e-b05c3c51905d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Contracture Management |
| Version Model Number | NS-6000-3002 |
| Catalog Number | NS-6000-3002 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 |
| 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 | 00840194499200 [Primary] |
| IQI | ORTHOSIS, LIMB BRACE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-10 |
| Device Publish Date | 2026-03-02 |
| 00840194499279 | Hinge with ExFix Connection Assembly Youth, Right |
| 00840194499262 | Hinge with ExFix Connection Assembly Youth, Left |
| 00840194499255 | Hinge with ExFix Connection Assembly Pediatric, Right |
| 00840194499248 | Hinge with ExFix Connection Assembly Pediatric, Left |
| 00840194499231 | Knee Thigh Cuff Assembly, XL |
| 00840194499224 | Knee Thigh Cuff Assembly, L |
| 00840194499217 | Knee Thigh Cuff Assembly, M |
| 00840194499200 | Knee Thigh Cuff Assembly, S |
| 00840194499194 | Knee Thigh Cuff Assembly, XS |