| Primary Device ID | 00841132146019 |
| NIH Device Record Key | 5d0ac5fc-76ad-4198-a0e4-386c65f77a07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PediFlex Advanced |
| Version Model Number | 01-1001-1001 |
| Catalog Number | 01-1001-1001 |
| 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 | true |
| 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 |
| Rzorn@OrthoPediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132146019 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-30 |
| Device Publish Date | 2018-03-28 |
| 00841132146019 | INSERTER BODY |
| 00841132146002 | METAL LID, SQUARE |
| 00841132145999 | INSERTER KNOB, SOLID |
| 00841132145982 | COLLET, 3.0mm |
| 00841132145975 | COLLET, 2.5mm |
| 00841132145968 | COLLET, 2.0mm |
| 00841132145951 | COLLET, 1.5mm |
| 00841132145692 | PEDIFLEX CONTAINER 1 ID CARD |
| 00841132145685 | METAL LID |
| 00841132145678 | PEDIFLEX TI IMPLANT TRAY |
| 00841132145661 | PEDIFLEX INSTRUMENT TRAY 1 |
| 00841132145654 | PEDIFLEX ADV - CONTAINER 1 |
| 00841132145647 | PEDIFLEX EXTRACTOR |
| 00841132145630 | SLOTTED MALLET |
| 00841132145623 | ROUND TIP 4.5MM X 450MM TI |
| 00841132145616 | ROUND TIP 4.0MM X 450MM TI |
| 00841132145609 | ROUND TIP 3.5MM X 400MM TI |
| 00841132145593 | ROUND TIP 3.0MM X 400MM TI |
| 00841132145586 | ROUND TIP 2.5MM X 300MM TI |
| 00841132145579 | ROUND TIP 2.0MM X 300MM TI |
| 00841132145562 | ROUND TIP 1.5MM X 300MM TI |
| 00841132145555 | PEDIFLEX CONTAINER 2 ID CARD |
| 00841132145548 | PEDIFLEX SS IMPLANT TRAY |
| 00841132145531 | PEDIFLEX INSTRUMENT TRAY 2 |
| 00841132145524 | PEDIFLEX ADV - CONTAINER 2 |
| 00841132145517 | ROUND TIP 4.0MM X 450MM SS |
| 00841132145500 | ROUND TIP 3.5MM X 400MM SS |
| 00841132145494 | ROUND TIP 3.0MM X 400MM SS |
| 00841132145487 | ROUND TIP 2.5MM X 300MM SS |
| 00841132145470 | ROUND TIP 2.0MM X 300MM SS |
| 00841132145463 | ROUND TIP 1.5MM X 300MM SS |
| 00841132145456 | INSERTER TAG |
| 00841132145449 | PEDIFLEX INSERTER TRAY |
| 00841132145432 | PEDIFLEX ADV - INSERTER CONTAINER |
| 00841132145425 | COLLET, 4.5MM |
| 00841132145418 | COLLET, 4.0MM |
| 00841132145401 | COLLET, 3.5MM |