BMT ASYMMETRIC PAT TEMPLATE SSI004631

GUDID 00887868262050

Biomet Orthopedics, LLC

Surgical implant template, reusable
Primary Device ID00887868262050
NIH Device Record Key91c760a1-e372-47b1-b0e3-96d422acecdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBMT ASYMMETRIC PAT TEMPLATE
Version Model NumberSSI004631
Catalog NumberSSI004631
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868262050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868262050]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

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

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