TWIST-OFFSCREW 110018523

GUDID 00887868138485

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00887868138485
NIH Device Record Key62cf9105-df7b-45c3-8d55-e110a0ab94b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTWIST-OFFSCREW
Version Model Number110018523
Catalog Number110018523
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 Datetrue
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
GS100887868138485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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]

00887868139055110018484
00887868139048110018483
00887868139031110018482
00887868139024110018481
00887868138508110018525
00887868138492110018524
00887868138485110018523
00887868138478110018522
00887868138461110018521
00887868138454110018520
00887868138447110018519
00887868138430110018518
00887868138423110018517
00887868138416110018516
00887868138409110018515
00887868138393110018514
00887868138386110018513
00887868138379110018512
00887868138362110018496
00887868138355110018495
00887868138348110018494
00887868138331110018493
00887868138324110018492
00887868138317110018491
00887868138300110018490
00887868138294110018489

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.