2.0MM SYSTEM SP-3081

GUDID 00888233021807

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, 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: 00888233021807
• NIH Device Record Key: 8b6ae6ae-49e3-4db4-b12d-3c651d2330c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0MM SYSTEM
• Version Model Number: SP-3081
• Catalog Number: SP-3081
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233021807 [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

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

[00888233021807]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2020-06-17

On-Brand Devices [2.0MM SYSTEM]

• 00841036282721: SP-2094
• 00841036282646: SP-2003
• 00841036241766: SP-3387
• 00841036227937: SP-3307
• 00841036219574: 91-2005-50
• 00841036219567: 91-2007-50
• 00841036219550: 91-2009-50
• 00841036219482: 91-6205-50
• 00841036219475: 91-6207-50
• 00841036209384: SP-3304
• 00841036209377: SP-3303
• 00841036206925: SP-3299
• 00841036203870: SP-3259
• 00841036199814: SP-1992
• 00841036199678: SP-1782
• 00841036199586: SP-1184
• 00841036199579: SP-1183
• 00841036178963: SP-3145
• 00841036174019: SP-3072
• 00841036174002: SP-3071
• 00841036173258: SP-3138
• 00841036173241: SP-3137
• 00841036173234: SP-3136
• 00841036173227: SP-3135
• 00841036173067: SP-3084
• 00841036173050: SP-3083
• 00841036173043: SP-3082
• 00841036173036: SP-3081
• 00841036173029: SP-3080
• 00841036173012: SP-3079
• 00841036173005: SP-3078
• 00841036172992: SP-3077
• 00841036172985: SP-3076
• 00841036172978: SP-3075
• 00841036172961: SP-3074
• 00841036172954: SP-3073
• 00841036172169: SP-3131-R
• 00841036172152: SP-3130-R
• 00841036172145: SP-3129-R
• 00841036172138: SP-3128-R
• 00841036172121: SP-3127-R
• 00841036172114: SP-3126-R
• 00841036172107: SP-3125-R
• 00841036172091: SP-3124-R
• 00841036172084: SP-3123-R
• 00841036172077: SP-3122-R
• 00841036172060: SP-3120-R
• 00841036172053: SP-3131-L
• 00841036172046: SP-3130-L
• 00841036172039: SP-3129-L