"2.0MM" SYSTEM PLATE 01-9288

GUDID 00841036017538

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, 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: 00841036017538
• NIH Device Record Key: 10d4c286-6209-4988-beee-e358fc0a999c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "2.0MM" SYSTEM PLATE
• Version Model Number: 01-9288
• Catalog Number: 01-9288
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036017538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

Moist Heat or Steam Sterilization

[00841036017538]

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 ["2.0MM" SYSTEM PLATE]

• 00841036083106: 01-6466
• 00841036017576: 01-9292
• 00841036017569: 01-9291
• 00841036017552: 01-9290
• 00841036017545: 01-9289
• 00841036017538: 01-9288
• 00841036017521: 01-9287
• 00841036017514: 01-9286
• 00841036017491: 01-9284
• 00841036017477: 01-9282
• 00841036017408: 01-9274
• 00841036017392: 01-9272
• 00841036017354: 01-9267
• 00841036017347: 01-9266
• 00841036017316: 01-9262
• 00841036017309: 01-9260
• 00841036017286: 01-9251
• 00841036017231: 01-9241
• 00841036017163: 01-9229
• 00841036017156: 01-9228
• 00841036017149: 01-9226
• 00841036017132: 01-9224
• 00841036017125: 01-9222
• 00841036017088: 01-9215
• 00841036017064: 01-9207
• 00841036017040: 01-9205
• 00841036016050: 01-8068
• 00841036016043: 01-8066
• 00841036015893: 01-8046
• 00841036015862: 01-8019
• 00841036015855: 01-8018
• 00841036011581: 01-6464
• 00841036011574: 01-6462
• 00841036011567: 01-6460
• 00841036011550: 01-6458
• 00841036011543: 01-6456
• 00841036011536: 01-6454
• 00841036011529: 01-6452
• 00841036011482: 01-6372
• 00841036011475: 01-6370
• 00841036011468: 01-6368
• 00841036011451: 01-6366
• 00841036011444: 01-6364
• 00841036011437: 01-6362
• 00841036011420: 01-6360