PNP TIBIA 01-1510-0036

GUDID 00840194466585

Large Head Pusher

ORTHOPEDIATRICS CORP.

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Primary Device ID00840194466585
NIH Device Record Key00aed277-8649-4da3-b680-2eaac35a6278
Commercial Distribution StatusIn Commercial Distribution
Brand NamePNP TIBIA
Version Model Number01-1510-0036
Catalog Number01-1510-0036
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
GS100840194466585 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


[00840194466585]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [PNP TIBIA]

00840194466875FLEXIBLE IM REAMER SHAFT 25IN
00840194466585Large Head Pusher

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