| Primary Device ID | 00841132128756 |
| NIH Device Record Key | ce9318f4-5df5-4e78-814a-55eec6e7bb3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Periacetabular Osteotomy System |
| Version Model Number | 01-1401-0005 |
| Catalog Number | 01-1401-0005 |
| 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 | 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 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com | |
| Phone | +1(574)268-6379 |
| Rbremer@orthopediatrics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132128756 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| 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 |
| 00841132128756 | PAO TRAY LID |
| 00841132128749 | PAO TRAY |
| 00841132128732 | DUAL-SPIKED PUBIS RETRACTOR |
| 00841132128725 | OFFSET CURVED OSTEOTOME, RIGHT |
| 00841132128718 | OFFSET CURVED OSTEOTOME, LEFT |
| 00840194478502 | Single Point Offset Pubis Retractor |
| 00840194478403 | PAO Special Pubis Retractor |