TRAUMAONE SYSTEM 43-1005

GUDID 00841036126551

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 00841036126551
• NIH Device Record Key: c8c06a94-cb2c-410e-a0f9-5c8cb966573c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUMAONE SYSTEM
• Version Model Number: 43-1005
• Catalog Number: 43-1005
• 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: 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
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036126551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081067

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

Moist Heat or Steam Sterilization

[00841036126551]

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 [TRAUMAONE SYSTEM]

• 00841036275389: SP-2244
• 00841036275242: 01-0292
• 00841036282783: SP-2194
• 00841036281694: 46-1505
• 00841036128562: 46-0006
• 00841036128548: 46-0015
• 00841036240806: SP-3386
• 00841036217600: SP-3310
• 00841036209483: SP-3301
• 00841036206918: SP-3295
• 00841036206901: SP-3294
• 00841036203887: SP-3260
• 00841036197629: 46-2463
• 00841036196042: SP-3248
• 00841036195618: SP-3247
• 00841036194413: SP-3238
• 00841036194406: SP-3237
• 00841036194390: SP-3236
• 00841036194253: SP-3228
• 00841036192914: SP-3222
• 00841036188542: SP-3207
• 00841036188535: SP-3206
• 00841036188528: SP-3205
• 00841036188511: SP-3204
• 00841036188504: SP-3203
• 00841036188498: SP-3202
• 00841036188481: SP-3201
• 00841036188474: SP-3200
• 00841036187910: SP-3221
• 00841036185459: SP-3208-R
• 00841036185442: SP-3209-R
• 00841036185435: SP-3210-R
• 00841036185428: SP-3210-L
• 00841036185411: SP-3211-L
• 00841036185404: SP-3211-R
• 00841036185398: SP-3209-L
• 00841036185374: SP-3208-L
• 00841036184353: 46-2462
• 00841036184179: SP-3196
• 00841036182465: 01-0292
• 00841036181123: 01-0298
• 00841036181062: 91-5711
• 00841036181055: 91-5709
• 00841036181048: 91-5707
• 00841036177645: SP-3070
• 00841036171704: SP-3054
• 00841036170837: SP-3053
• 00841036170752: SP-3058
• 00841036170745: SP-3057
• 00841036170288: SP-3059