TWIST- OFFSCREW 110018508

GUDID 00887868139208

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00887868139208
NIH Device Record Key3e27c1e5-36ac-423c-a888-80cb6a8fea21
Commercial Distribution StatusIn Commercial Distribution
Brand NameTWIST- OFFSCREW
Version Model Number110018508
Catalog Number110018508
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 Usetrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868139208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868139208]

Moist Heat or Steam Sterilization


[00887868139208]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [TWIST- OFFSCREW]

00887868139239110018511
00887868139222110018510
00887868139215110018509
00887868139208110018508
00887868139192110018507
00887868139185110018506
00887868139178110018505
00887868139161110018504
00887868139154110018503
00887868139147110018502
00887868139130110018501
00887868139123110018500
00887868139116110018499
00887868139109110018498
00887868139093110018488
00887868139086110018487
00887868139079110018486
00887868139062110018485

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