Primary Device ID | 07540194010469 |
NIH Device Record Key | f060d2ee-9699-4bcd-bfa0-5f7f7ac9ac75 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dr.Paleys Osteotomy System |
Version Model Number | DRP-CASE |
Catalog Number | DRP-CASE |
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 | false |
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 | |
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 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *keep at room temperature |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540194010469 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
[07540194010469]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-08-20 |
Device Publish Date | 2020-08-12 |
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 |