ACTIVE ARTICULATION™ HIP SYSTEM INLAY HEAD PRESS 31-139274

GUDID 00880304535350

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00880304535350
NIH Device Record Keye66cdbbb-a04a-4767-bd03-52b97108a183
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTIVE ARTICULATION™ HIP SYSTEM INLAY HEAD PRESS
Version Model Number31-139274
Catalog Number31-139274
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
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304535350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


[00880304535350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-10-28

Devices Manufactured by Biomet Orthopedics, LLC

00887868254451 - Comprehensive® Reverse Shoulder2024-11-21
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

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