INTERMAXILLARY FIXATION SYSTEM SP-3017

GUDID 00841036163778

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00841036163778
NIH Device Record Keyda78dc44-7057-43c0-99d2-e77d8f7fe8e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTERMAXILLARY FIXATION SYSTEM
Version Model NumberSP-3017
Catalog NumberSP-3017
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
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036163778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLSCREW, FIXATION, INTRAOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

Moist Heat or Steam Sterilization


[00841036163778]

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 [INTERMAXILLARY FIXATION SYSTEM]

00841036168186SP-3017-10
00841036168179SP-3017-05
00841036163778SP-3017
0084103605662995-5213
0084103605371091-5215
0084103605370391-5213
00888233021388SP-3017-10
00888233021371SP-3017-05
00888233021364SP-3017

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