Orthex Tool H505

GUDID 00841132178102

Orthex, Handle, AO Pull Adpt

ORTHOPEDIATRICS CORP.

Surgical instrument handle, torque-limiting
Primary Device ID00841132178102
NIH Device Record Key3edf4961-86a3-4f2c-a9af-f877effe9b20
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthex Tool
Version Model NumberH505
Catalog NumberH505
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 Batchfalse
Serial Numbertrue
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
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132178102 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132178102]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

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00841132178102Orthex, Handle, AO Pull Adpt

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