| Primary Device ID | 00840194462815 |
| NIH Device Record Key | 33bc4f7a-67b5-4e7f-95d8-8451aa2d9e52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dynamic Femur Fracture Brace |
| Version Model Number | NS-DF2B-0001 |
| Catalog Number | NS-DF2B-0001 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840194462815 [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 | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
| 00840194462921 | XXL DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462914 | XXL DF2 Femur Fracture Brace, Left, Static Knee |
| 00840194462907 | XL DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462891 | XL DF2 Femur Fracture Brace, Left, Static Knee |
| 00840194462884 | L DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462877 | L DF2 Femur Fracture Brace, Left, Static Knee |
| 00840194462860 | M DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462853 | M DF2 Femur Fracture Brace, Left, Static Knee |
| 00840194462846 | S DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462839 | S DF2 Femur Fracture Brace, Left, Static Knee |
| 00840194462822 | XS DF2 Femur Fracture Brace, Right, Static Knee |
| 00840194462815 | XS DF2 Femur Fracture Brace, Left, Static Knee |