| Primary Device ID | 00841132131794 |
| NIH Device Record Key | 90344502-a459-4e5a-943d-6d4663168d4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PediFrag System |
| Version Model Number | 00-1005-4044 |
| Catalog Number | 00-1005-4044 |
| 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 | 00841132131794 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-31 |
| 00841132131824 | 4.0MM CANNULATED CANCELLOUS SCREW, T15 HEXALOBE, PARTIAL THREAD, 12MM |
| 00841132131817 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 48 MM |
| 00841132131800 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 46 MM |
| 00841132131794 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 44 MM |
| 00841132131787 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 42MM |
| 00841132131770 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 38 MM |
| 00841132131763 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 36 MM |
| 00841132131756 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 34 MM |
| 00841132131749 | 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 32 MM |