POWERTEK II PLUS SHAVER SYSTEM 906064

GUDID 00880304454538

Biomet Orthopedics, LLC

Arthroscopic shaver system, line-powered
Primary Device ID00880304454538
NIH Device Record Key5f5e5694-c0cf-4b10-88f6-6e89f5b66372
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOWERTEK II PLUS SHAVER SYSTEM
Version Model Number906064
Catalog Number906064
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
GS100880304454538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

Moist Heat or Steam Sterilization


[00880304454538]

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

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
00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR2024-09-11

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