ALLTHREAD(TM) ANCHOR AWL 905955

GUDID 00880304464377

Biomet Orthopedics, LLC

Bone awl
Primary Device ID00880304464377
NIH Device Record Keyed7d63db-491a-4c3f-94bc-cb77925585e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLTHREAD(TM) ANCHOR AWL
Version Model Number905955
Catalog Number905955
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304464377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone
HWPPUNCH, FEMORAL NECK

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


[00880304464377]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-23
Device Publish Date2017-07-28

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00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11
00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR2024-09-11

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