Orthopediatric Instrumentation 01-9100-3525

GUDID 00840194405362

2.5mm THREADED DRILL GUIDE

ORTHOPEDIATRICS CORP.

Surgical drill guide, reusable
Primary Device ID00840194405362
NIH Device Record Key15cf8dd9-4ef2-4960-891a-6f86532b19d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthopediatric Instrumentation
Version Model Number01-9100-3525
Catalog Number01-9100-3525
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

Customer Support Contacts

Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194405362 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


[00840194405362]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-03
Device Publish Date2021-09-01

On-Brand Devices [Orthopediatric Instrumentation]

008401944053551.6mm THREADED WIRE GUIDE
008401944053312.0mm THREADED WIRE GUIDE
008401944053865.0mm HEX TOWER GUIDE DRIVER
008401944053622.5mm THREADED DRILL GUIDE
008401944053483.2mm THREADED DRILL GUIDE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.