Orthex Tool PP460-15-110

GUDID 00841132179888

Wire Sleeve, SB 4.5x1.5x110mm

ORTHOPEDIATRICS CORP.

Surgical drill guide, reusable
Primary Device ID00841132179888
NIH Device Record Keyfcee5818-5a3c-45e8-89e2-5c7d5c6f482f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthex Tool
Version Model NumberPP460-15-110
Catalog NumberPP460-15-110
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132179888 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132179888]

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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