"1.5MM" SYSTEM 01-7131-K

GUDID 00841036133191

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: 00841036133191
• NIH Device Record Key: 1d78b31b-8c08-4222-9436-773b3561becc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "1.5MM" SYSTEM
• Version Model Number: 01-7131-K
• Catalog Number: 01-7131-K
• 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: false
• 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	00841036133191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953385

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

[00841036133191]

Moist Heat or Steam Sterilization

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 ["1.5MM" SYSTEM]

• 00841036133207: 01-7136-K
• 00841036133191: 01-7131-K
• 00841036133184: 01-7130-K
• 00841036133177: 01-7128-K
• 00841036133160: 01-7126-K
• 00841036133054: 01-7062-K
• 00841036133023: 01-7050-K
• 00841036131128: 01-7040-K
• 00841036076061: 99-7208
• 00841036068776: 91-1809
• 00841036064839: 01-6489
• 00841036060978: 91-1508
• 00841036057749: 99-7227
• 00841036057732: 99-7225
• 00841036057725: 99-7223
• 00841036057718: 99-7215
• 00841036057701: 99-7213
• 00841036057695: 99-7211
• 00841036057688: 99-7209
• 00841036057671: 99-7207
• 00841036057664: 99-7206
• 00841036057657: 99-7205
• 00841036057640: 99-7204
• 00841036057633: 99-7203
• 00841036056681: 95-6107
• 00841036056674: 95-6106
• 00841036056667: 95-6105
• 00841036056650: 95-6104
• 00841036056643: 95-6103
• 00841036056278: 95-1809
• 00841036056261: 95-1807
• 00841036056254: 95-1805
• 00841036056247: 95-1803
• 00841036056230: 95-1515
• 00841036056223: 95-1513
• 00841036056216: 95-1511
• 00841036056209: 95-1509
• 00841036056193: 95-1508
• 00841036056186: 95-1507
• 00841036056179: 95-1506
• 00841036056162: 95-1505
• 00841036056155: 95-1504
• 00841036056148: 95-1503
• 00841036053765: 91-6107
• 00841036053758: 91-6106
• 00841036053741: 91-6105
• 00841036053734: 91-6104
• 00841036053727: 91-6103
• 00841036053352: 91-1807
• 00841036053345: 91-1805