ExploR® Radial Head Plating System IFI-491435

GUDID 00880304826618

Biomet Orthopedics, LLC

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID00880304826618
NIH Device Record Keya272d6ed-2bb9-4d18-9182-79ab9d612ecd
Commercial Distribution StatusIn Commercial Distribution
Brand NameExploR® Radial Head Plating System
Version Model NumberIFI-491435
Catalog NumberIFI-491435
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304826618 [Primary]
GS100880304826618 [Primary]
GS100880304826618 [Primary]
GS100880304826618 [Primary]

FDA Product Code

LXIGuide, drill, ligament
LXIGuide, drill, ligament
LXIGuide, drill, ligament
LXIGuide, drill, ligament

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304826618]

Moist Heat or Steam Sterilization


[00880304826618]

Moist Heat or Steam Sterilization


[00880304826618]

Moist Heat or Steam Sterilization


[00880304826618]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [ExploR® Radial Head Plating System]

00880304826632IFI-491443
00880304826625IFI-491438
00880304826601IFI-491433
00880304826595IFI-491430
00880304826588IFI-491422
00880304826564IFI-491407
00880304826618IFI-491435

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