| Primary Device ID | 00841132119389 |
| NIH Device Record Key | 2bb62dd5-adf7-4d71-889a-40c690686687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoPediatrics PediFlex Flexible Nail System |
| Version Model Number | 00-1000-035 |
| Catalog Number | 00-1000-035 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132119389 [Primary] |
| HTY | PIN, FIXATION, SMOOTH |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-28 |
| 00841132119655 | ø4.5mm x 450mm Round Tip Flexible IM Nail |
| 00841132119648 | ø4.0mm x 450mm Round Tip Flexible IM Nail |
| 00841132119631 | ø3.5mm x 400mm Round Tip Flexible IM Nail |
| 00841132119624 | ø3.0mm x 400mm Round Tip Flexible IM Nail |
| 00841132119617 | ø2.5mm x 300mm Round Tip Flexible IM Nail |
| 00841132119600 | ø2.0mm x 300mm Round Tip Flexible IM Nail |
| 00841132119594 | ø1.5mm x 300mm Round Tip Flexible IM Nail |
| 00841132119525 | ø3.5mm x 400mm Flexible IM Nail |
| 00841132119518 | ø3.0mm x 400mm Flexible IM Nail |
| 00841132119501 | ø2.5mm x 300mm Flexible IM Nail |
| 00841132119495 | ø2.0mm x 300mm Flexible IM Nail |
| 00841132119488 | ø1.5mm x 300mm Flexible IM Nail |
| 00841132119471 | ø4.5mm Flexible IM Nail Cap (2 Each) |
| 00841132119464 | ø4.0mm Flexible IM Nail Cap (2 Each) |
| 00841132119457 | ø3.5mm Flexible IM Nail Cap (2 Each) |
| 00841132119440 | ø3.0mm Flexible IM Nail Cap (2 Each) |
| 00841132119433 | ø2.5mm Flexible IM Nail Cap (2 Each) |
| 00841132119426 | ø2.0mm Flexible IM Nail Cap (2 Each) |
| 00841132119419 | ø1.5mm Flexible IM Nail Cap (2 Each) |
| 00841132119402 | ø4.5mm x 450mm Flexible IM Nail |
| 00841132119396 | ø4.0mm x 450mm Flexible IM Nail |
| 00841132119389 | ø3.5mm x 400mm Flexible IM Nail |
| 00841132119372 | ø3.0mm x 400mm Flexible IM Nail |
| 00841132119365 | ø2.5mm x 300mm Flexible IM Nail |
| 00841132119358 | ø1.5mm x 300mm Flexible IM Nail |
| 00841132100059 | Ø2.0 MM X 300 MM FLEXIBLE IM NAIL |