"2.4MM" LOCKING RECON SYSTEM 99-2693

GUDID 00841036091507

BIOMET MICROFIXATION, INC

Temporary mandibular condyle prosthesis
Primary Device ID00841036091507
NIH Device Record Key8c5403b8-a9a7-4fc7-af16-32067483ccac
Commercial Distribution StatusIn Commercial Distribution
Brand Name"2.4MM" LOCKING RECON SYSTEM
Version Model Number99-2693
Catalog Number99-2693
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
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 Usetrue
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

Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036091507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEIProsthesis, condyle, mandibular, temporary

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036091507]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-11

On-Brand Devices ["2.4MM" LOCKING RECON SYSTEM]

0084103615079201-2635
0084103609150799-2693
0084103601036201-2949
0084103600984701-2692
0084103600983001-2691

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