"1.5MM" SYSTEM PLATE 01-7065

GUDID 00841036012618

BIOMET MICROFIXATION, INC

Cranioplasty plate, alterable
Primary Device ID00841036012618
NIH Device Record Key3f3b4a14-45d9-4bb8-9381-1c7a4823bee0
Commercial Distribution StatusIn Commercial Distribution
Brand Name"1.5MM" SYSTEM PLATE
Version Model Number01-7065
Catalog Number01-7065
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
GS100841036012618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFASTENER, PLATE, CRANIOPLASTY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036012618]

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 ["1.5MM" SYSTEM PLATE]

0084103615071601-7135
0084103613330601-7363-K
0084103613329001-7361-K
0084103613328301-7359-K
0084103613327601-7357-K
0084103613326901-7355-K
0084103613325201-7353-K
0084103613324501-7351-K
0084103613323801-7347-K
0084103613322101-7345-K
0084103613321401-7306-K
0084103613315301-7114-K
0084103613314601-7112-K
0084103613313901-7110-K
0084103613312201-7104-K
0084103613311501-7102-K
0084103613310801-7100-K
0084103613309201-7093-K
0084103613308501-7092-K
0084103613307801-7090-K
0084103613306101-7066-K
0084103613304701-7057-K
0084103613303001-7055-K
0084103613187601-7137-K
0084103613186901-7308-K
0084103613185201-7309-K
0084103613183801-7310-K
0084103605290480-7305
0084103601369101-7305
0084103601338701-7185
0084103601337001-7182
0084103601336301-7180
0084103601297701-7109
0084103601296001-7108
0084103601295301-7107
0084103601294601-7106
0084103601290801-7096
0084103601281601-7086
0084103601280901-7085
0084103601275501-7079
0084103601274801-7078
0084103601271701-7075
0084103601270001-7074
0084103601267001-7071
0084103601266301-7070
0084103601265601-7069
0084103601264901-7068
0084103601263201-7067
0084103601261801-7065
0084103601251901-7037

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