"1.5MM" SYSTEM 91-1805

GUDID 00841036053345

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00841036053345
NIH Device Record Keyb162dc21-6c14-4ca7-b919-e5e88a1eb7e9
Commercial Distribution StatusIn Commercial Distribution
Brand Name"1.5MM" SYSTEM
Version Model Number91-1805
Catalog Number91-1805
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
GS100841036053345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBWFASTENER, PLATE, CRANIOPLASTY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036053345]

Moist Heat or Steam Sterilization


[00841036053345]

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]

0084103613320701-7136-K
0084103613319101-7131-K
0084103613318401-7130-K
0084103613317701-7128-K
0084103613316001-7126-K
0084103613305401-7062-K
0084103613302301-7050-K
0084103613112801-7040-K
0084103607606199-7208
0084103606877691-1809
0084103606483901-6489
0084103606097891-1508
0084103605774999-7227
0084103605773299-7225
0084103605772599-7223
0084103605771899-7215
0084103605770199-7213
0084103605769599-7211
0084103605768899-7209
0084103605767199-7207
0084103605766499-7206
0084103605765799-7205
0084103605764099-7204
0084103605763399-7203
0084103605668195-6107
0084103605667495-6106
0084103605666795-6105
0084103605665095-6104
0084103605664395-6103
0084103605627895-1809
0084103605626195-1807
0084103605625495-1805
0084103605624795-1803
0084103605623095-1515
0084103605622395-1513
0084103605621695-1511
0084103605620995-1509
0084103605619395-1508
0084103605618695-1507
0084103605617995-1506
0084103605616295-1505
0084103605615595-1504
0084103605614895-1503
0084103605376591-6107
0084103605375891-6106
0084103605374191-6105
0084103605373491-6104
0084103605372791-6103
0084103605335291-1807
0084103605334591-1805

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