Periacetabular Osteotomy System 01-1401-0007

GUDID 00840194478502

Single Point Offset Pubis Retractor

ORTHOPEDIATRICS CORP.

Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable Hand-held surgical retractor, reusable
Primary Device ID00840194478502
NIH Device Record Key75eaed15-4d78-487c-a087-d7c9d9f0458b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeriacetabular Osteotomy System
Version Model Number01-1401-0007
Catalog Number01-1401-0007
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194478502 [Primary]

FDA Product Code

GADRETRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


[00840194478502]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-07
Device Publish Date2024-05-30

On-Brand Devices [Periacetabular Osteotomy System]

00841132128756PAO TRAY LID
00841132128749PAO TRAY
00841132128732DUAL-SPIKED PUBIS RETRACTOR
00841132128725OFFSET CURVED OSTEOTOME, RIGHT
00841132128718OFFSET CURVED OSTEOTOME, LEFT
00840194478502Single Point Offset Pubis Retractor
00840194478403PAO Special Pubis Retractor

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