TMJ SYSTEM 01-6587

GUDID 00888233005432

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
Primary Device ID00888233005432
NIH Device Record Keyc412b139-c3b3-4abc-9ccd-3b4784a366d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMJ SYSTEM
Version Model Number01-6587
Catalog Number01-6587
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]
GS100888233005432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE
JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


[00888233005432]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-31
Device Publish Date2020-06-17

On-Brand Devices [TMJ SYSTEM]

008410360363792.0MM/ 2.7MM TMJ DOUBLE ENDED DRILL GUIDE
00841036198121SP-1874-INT
00841036155100SP-2896
00841036151348SP-1873-INT
008410361475492.3X11MM FOSSA CROSS-DRIVE SCREW
008410361401442.3X5MM FOSSA CROSS-DRIVE SCREW
008410361387762.0X13MM FOSSA CROSS-DRIVE SCREW
00841036134204SP-2328
00841036134198SP-2327
00841036129309INSTRUMENT TRAY
008410361286922.0X5MM FOSSA CROSS-DRIVE SCREW
00841036124991SCREW / TRIAL TRAY
0084103608189850 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
0084103608188150 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
0084103608187445 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
0084103608186745 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
0084103608180550 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT
0084103608179950 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT
0084103608178245 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT
0084103608174455 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103608173750 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103608172050 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103608171345 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103608156045 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT
0084103608155345 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT
0084103608138645 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT
0084103608134855 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103607511845 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
0084103606488450 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT
0084103606358050 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT
00841036060534TWIST DRILL WITH J-NOTCH 2.2X70,12STP
0084103606042850MM RIGHT STANDARD MANDIBULAR COMPONENT
0084103606039855 MM RIGHT STANDARD MANDIBULAR COMPONENT
0084103606034350 MM RIGHT STANDARD MANDIBULAR COMPONENT
0084103606032950 MM LEFT STANDARD MANDIBULAR COMPONENT
008410360574802.3X9MM FOSSA CROSS-DRIVE SCREW
008410360574732.3X7MM FOSSA CROSS-DRIVE SCREW
008410360574662.0X11MM FOSSA CROSS-DRIVE SCREW
008410360574592.0X9MM FOSSA CROSS-DRIVE SCREW
008410360574422.0X7MM FOSSA CROSS-DRIVE SCREW
00841036039271DINGMAN BONE HOLDING FORCEPS HEAVY PATTERN
00841036039264DINGMAN BONE HOLDING FORCEPS LIGHT PATTERN
00841036036683TWIST DRILL WITH J-NOTCH 2.2X115,12STP
00841036036676TWIST DRILL WITH J-NOTCH 2.0X115,12STP
00841036036669TWIST DRILL WITH J-NOTCH 2.0X70,12STP
00841036036652TWIST DRILL WITH J-NOTCH 1.5X105,11 STP
00841036036645TWIST DRILL WITH J-NOTCH 1.5X50,11 STP
00841036036638LEFT FOSSA COMPONENT TRIAL LARGE
00841036036621LEFT FOSSA COMPONENT, LARGE
00841036036614RIGHT FOSSA COMPONENT TRIAL LARGE

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