STERILE TRAC SYSTEM 12 PACK 15-1803-12

GUDID 00841036133504

BIOMET MICROFIXATION, INC

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 00841036133504
• NIH Device Record Key: 4935942d-9a3c-478a-8660-4a2f2e8b88d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILE TRAC SYSTEM 12 PACK
• Version Model Number: 15-1803-12
• Catalog Number: 15-1803-12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036133504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972322

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 12 PACK]

• 00841036199128: SP-STA-2139-12
• 00841036199111: SP-STA-2281-12
• 00841036199098: SP-STA-2250-12
• 00841036199074: SP-STA-2249-12
• 00841036199043: SP-STA-2138-12
• 00841036199029: SP-STA-2136-12
• 00841036199005: SP-STA-2135-12
• 00841036198985: SP-STA-2090-12
• 00841036198961: SP-STA-2087-12
• 00841036198947: SP-STA-2082-12
• 00841036198923: SP-STA-1842-12
• 00841036198909: SP-STA-1841-12
• 00841036198886: SP-STA-1837-12
• 00841036198862: SP-STA-1836-12
• 00841036198848: SP-STA-1798-12
• 00841036198824: SP-STA-1797-12
• 00841036198800: SP-STA-1796-12
• 00841036198787: SP-STA-1343-12
• 00841036198763: SP-STA-1055-12
• 00841036198749: SP-STA-1035-12
• 00841036198725: SP-STA-1030-12
• 00841036198701: SP-STA-1025-12
• 00841036198688: SP-STA-1021-12
• 00841036198664: SP-ST-7345N-12
• 00841036198657: SP-ST-7309N-12
• 00841036198619: SP-ST-7308-12
• 00841036198589: SP-ST-6903-12
• 00841036198565: SP-ST-6704-12
• 00841036198558: SP-ST-6703-12
• 00841036198541: SP-ST-6105X-12
• 00841036198534: SP-ST-6105-12
• 00841036198510: SP-ST5-6703-12
• 00841036198497: SP-ST5-6105X-12
• 00841036198480: SP-ST5-6104-12
• 00841036198473: SP-ST2-6704-12
• 00841036198459: SP-ST2-6703-12
• 00841036198435: SP-ST2-6105X-12
• 00841036198428: SP-ST2-6104-12
• 00841036198411: SP-ST2-6103-12
• 00841036198404: SP-ST-1942-12
• 00841036198381: SP-ST-1863-12
• 00841036198374: SP-ST-1075-12
• 00841036198350: SP-ST-1070-12
• 00841036198336: SP-ST-1065-12
• 00841036198329: SP-ST-1060-12
• 00841036198305: SP-ST-1050-12
• 00841036198282: SP-ST-1045-12
• 00841036198268: SP-ST-1040-12
• 00841036198244: SP-ST-1020-12
• 00841036198237: SP-ST-1019-12