Dr.Paleys Osteotomy System DRPFO-201

GUDID 07540194016034

OUTRIGGER CORA PIN

Pega Medical Inc

Orthopaedic instrument surgical connector

• Primary Device ID: 07540194016034
• NIH Device Record Key: 7b4c7b44-b5cb-4a60-b1ef-cda28ae56a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr.Paleys Osteotomy System
• Version Model Number: DRPFO-201
• Catalog Number: DRPFO-201
• 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: 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

Customer Support Contacts

• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca
• Phone: +1(450)688-5144
• Email: egarcia@orthopediatrics.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540194016034 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

[07540194016034]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-19
• Device Publish Date: 2024-09-11

On-Brand Devices [Dr.Paleys Osteotomy System]

• 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