"1.0MM" SYSTEM 99-7403

GUDID 00841036057947

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00841036057947
NIH Device Record Key389dac52-dca2-49ad-9264-d0111c272d5f
Commercial Distribution StatusIn Commercial Distribution
Brand Name"1.0MM" SYSTEM
Version Model Number99-7403
Catalog Number99-7403
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
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036057947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFASTENER, PLATE, CRANIOPLASTY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036057947]

Moist Heat or Steam Sterilization


[00841036057947]

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

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0084103605798599-7407
0084103605797899-7406
0084103605796199-7405
0084103605795499-7404
0084103605794799-7403
0084103605793099-7402
0084103605792399-7385
0084103605791699-7383
0084103605790999-7377
0084103605789399-7376
0084103605788699-7375
0084103605787999-7374
0084103605786299-7373
0084103605785599-7372
0084103601432201-7453
0084103601430801-7450
0084103601429201-7446
0084103601406301-7383
0084103601402501-7377
0084103601401801-7376
0084103601400101-7375
0084103601399801-7374
0084103601398101-7373
0084103601397401-7372

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