STERILE TRAC SYSTEM 25-1005

GUDID 00841036133573

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 00841036133573
• NIH Device Record Key: 2d10d722-1d82-4870-af9e-8bd73ed8e9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILE TRAC SYSTEM
• Version Model Number: 25-1005
• Catalog Number: 25-1005
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036133573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953385

FDA Product Code

• JEY: PLATE, BONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices [STERILE TRAC SYSTEM]

• 00841036199104: SP-STA-2281
• 00841036199081: SP-STA-2250
• 00841036199067: SP-STA-2249
• 00841036199050: SP-STA-2139
• 00841036199036: SP-STA-2138
• 00841036199012: SP-STA-2136
• 00841036198992: SP-STA-2135
• 00841036198978: SP-STA-2090
• 00841036198954: SP-STA-2087
• 00841036198930: SP-STA-2082
• 00841036198916: SP-STA-1842
• 00841036198893: SP-STA-1841
• 00841036198879: SP-STA-1837
• 00841036198855: SP-STA-1836
• 00841036198831: SP-STA-1798
• 00841036198817: SP-STA-1797
• 00841036198794: SP-STA-1796
• 00841036198770: SP-STA-1343
• 00841036198756: SP-STA-1055
• 00841036198732: SP-STA-1035
• 00841036198718: SP-STA-1030
• 00841036198695: SP-STA-1025
• 00841036198671: SP-ST-7347N
• 00841036198640: SP-ST-7309N
• 00841036198633: SP-ST-7309
• 00841036198626: SP-ST-7308N
• 00841036198602: SP-ST-7308
• 00841036198596: SP-ST-7305
• 00841036198572: SP-ST-6903
• 00841036198527: SP-ST5-6704
• 00841036198503: SP-ST5-6703
• 00841036198466: SP-ST2-6704
• 00841036198442: SP-ST2-6703
• 00841036198398: SP-ST-1942
• 00841036198367: SP-ST-1075
• 00841036198343: SP-ST-1070
• 00841036198312: SP-ST-1060
• 00841036198299: SP-ST-1050
• 00841036198275: SP-ST-1045
• 00841036198251: SP-ST-1020B
• 00841036198220: SP-ST-1019
• 00841036198206: SP-ST-1015
• 00841036198176: SP-3099
• 00841036198152: SP-3094
• 00841036198145: SP-3093
• 00841036194758: SP-ST2-6105
• 00841036194741: SP-ST-6105X
• 00841036194734: SP-ST-6105
• 00841036194727: SP-ST2-6104
• 00841036194710: SP-ST2-6103