SELEX INSERTER HANDLE S313131

GUDID 00880304432277

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting
Primary Device ID00880304432277
NIH Device Record Key2018c6ba-dd35-4c55-9ab1-73e1d736cd20
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELEX INSERTER HANDLE
Version Model NumberS313131
Catalog NumberS313131
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304432277 [Primary]

FDA Product Code

MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304432277]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2017-07-28

On-Brand Devices [SELEX INSERTER HANDLE]

0088030471645286-S313131
00880304432277S313131

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