POWERTEK II PLUS SHAVER 906063

GUDID 00880304460492

Biomet Orthopedics, LLC

Arthroscopic shaver system handpiece, line-powered
Primary Device ID00880304460492
NIH Device Record Key04113642-c0f6-4b16-8b5c-5b178c7d031a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOWERTEK II PLUS SHAVER
Version Model Number906063
Catalog Number906063
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304460492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


[00880304460492]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

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00887868578250 - Comprehensive®2024-11-13
08428898885684 - BIPASS DISPOSABLE PUSHER2024-09-11
08428898885691 - BIPASS DISPOSABLE PUSHER2024-09-11
00880304338548 - AGC ANTERIOR FILE2024-09-11
00880304339224 - PARALLEL PULLER2024-09-11
00880304342187 - AGC MODULAR TIBIAL II2024-09-11
00880304365247 - BIO-MODULAR2024-09-11

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