1.5MM SYSTEM 01-8678

GUDID 00841036123338

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 00841036123338
• NIH Device Record Key: 07b53fb0-545b-409b-82fa-cde74122379f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5MM SYSTEM
• Version Model Number: 01-8678
• Catalog Number: 01-8678
• 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
• 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	00841036123338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GXR: COVER, BURR HOLE

Sterilization

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

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

Moist Heat or Steam Sterilization

[00841036123338]

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]

• 00841036270148: 72-3100
• 00841036282776: SP-2187
• 00841036282707: SP-2062
• 00841036282691: SP-2061
• 00841036282684: SP-2060
• 00841036282653: SP-2029
• 00841036136253: 01-7189
• 00841036282219: 01-8613
• 00841036282202: 01-8612
• 00841036282196: 01-8611
• 00841036282189: 01-8610
• 00841036237097: SP-3333
• 00841036237080: SP-3332
• 00841036237073: SP-3331
• 00841036237066: SP-3330
• 00841036237059: SP-3329
• 00841036237042: SP-3328
• 00841036237035: SP-3327
• 00841036237028: SP-3326
• 00841036237011: SP-3325
• 00841036237004: SP-3324
• 00841036236991: SP-3314
• 00841036236984: SP-3313
• 00841036236977: SP-3312
• 00841036236731: SP-3444
• 00841036236724: SP-3445
• 00841036229993: SP-3337
• 00841036229986: SP-3336
• 00841036226510: SP-2082
• 00841036226503: SP-1842
• 00841036219512: 91-6103-50
• 00841036219505: 91-6104-50
• 00841036219499: 91-6105X-50
• 00841036214104: SP-3300
• 00841036212810: SP-3318
• 00841036202972: SP-3258
• 00841036202965: SP-3257
• 00841036202958: SP-3256
• 00841036197643: SP-3224
• 00841036195786: SP-3227
• 00841036194451: SP-3216
• 00841036191146: SP-3217
• 00841036189952: SP-3223
• 00841036188825: SP-3220
• 00841036188818: SP-3002
• 00841036187934: SP-3213
• 00841036187927: SP-3212
• 00841036185992: SP-3214
• 00841036185466: SP-3190
• 00841036182267: SP-3187