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Dr.Paleys Osteotomy System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Canada ULC

Identity

Trade Name
Dr.Paleys Osteotomy System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
FULL DR PALEY INSTRUMENT CASE - 2ND GEN FDA UDI
Model / Reference
DRP-INF250 FDA UDI
Description
FULL DR PALEY INSTRUMENT CASE - 2ND GEN FDA UDI

Identifiers

Catalog Number
DRP-INF250 FDA UDI
Primary DI / UDI-DI
07540194015815 FDA UDI
FDA Product Code
OJH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Dr.Paleys Osteotomy System by Orthopediatrics Canada ULC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Canada ULC

Sources (1)

  • FDA UDI c40dfda0-d4b1-4c27-af9b-46727160ac55 35 fields · synced Jun 8, 2026