| Primary Device ID | 07540194012852 |
| NIH Device Record Key | 02fb6e8b-0048-43d1-a022-6263c5bfb286 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dr.Paleys Osteotomy System |
| Version Model Number | DRPFO-106 |
| Catalog Number | DRPFO-106 |
| Company DUNS | 257315713 |
| Company Name | Pega Medical Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com | |
| Phone | +1(450)688-5144 |
| egarcia@pegamedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540194012852 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
[07540194012852]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-22 |
| Device Publish Date | 2021-04-14 |
| 07540194010681 | Dr PALEY RIGHT ANGLE CLAMP |
| 07540194010674 | Dr PALEY PERIOSTEAL ELEVATOR |
| 07540194010667 | Dr PALEY OSTEOTOME LEVER |
| 07540194010650 | Dr PALEY OSTEOTOME 10 mm |
| 07540194010643 | Dr PALEY OSTEOTOME 8 mm |
| 07540194010636 | Dr PALEY OSTEOTOME 6 mm WITH GUIDE |
| 07540194010629 | Dr PALEY OSTEOTOME 4 mm |
| 07540194010612 | PALM HANDLE FOR ASSEMBLY (G-030101_CC) |
| 07540194010605 | Dr PALEY GIGLI PASSER TUBE |
| 07540194010599 | Dr PALEY GIGLI PASSER CURVED |
| 07540194010582 | Dr PALEY GIGLI PASSER TUBE |
| 07540194010575 | Dr PALEY GIGLI PASSER STRAIGHT |
| 07540194010568 | Dr PALEY FEMORAL OUTRIGGER |
| 07540194010551 | Dr PALEY FASCIOTOME |
| 07540194010544 | Dr PALEY DRILL GUIDE |
| 07540194010537 | Dr PALEY CORA PIN |
| 07540194010520 | Dr PALEY DRILL Ø4.8mm |
| 07540194010513 | Dr PALEY CURVED CLAMP |
| 07540194010506 | Dr PALEY BEAM COMPASS |
| 07540194010490 | Dr PALEY AUXILIARY PIN |
| 07540194010483 | FULL Dr PALEY INSTRUMENT CASE |
| 07540194010476 | Dr PALEY INSTRUMENT CASE RENTAL |
| 07540194010469 | EMPTY Dr PALEY INSTRUMENT CASE |
| 07540194012869 | Dr PALEY OUTRIGGER CLAMP |
| 07540194012852 | Dr PALEY OUTRIGGER TIGHTENING SCREW |
| 07540194012845 | Dr PALEY OUTRIGGER SPACER TUBE |
| 07540194012838 | Dr PALEY OUTRIGGER PIN LINK |
| 07540194012821 | Dr PALEY OUTRIGGER CORA PIN |
| 07540194015815 | FULL DR PALEY INSTRUMENT CASE - 2ND GEN |
| 07540194015075 | EMPTY DR PALEY INSTRUMENT CASE - 2ND GEN |
| 07540194016010 | PEDIATRIC OSTEOTOME SET - FULL CASE |
| 07540194016003 | PEDIATRIC OSTEOTOME SET - EMPTY CASE |
| 07540194016041 | CORA PIN |
| 07540194016034 | OUTRIGGER CORA PIN |
| 07540194015976 | Dr PALEY BEAM COMPASS |