CMF SYSTEM SP-2097

GUDID 00841036282738

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: 00841036282738
• NIH Device Record Key: 3b3ee1a3-cb9a-4d27-a1a2-6442721d360a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMF SYSTEM
• Version Model Number: SP-2097
• Catalog Number: SP-2097
• 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	00841036282738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

[00841036282738]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-06
• Device Publish Date: 2020-03-27

On-Brand Devices [CMF SYSTEM]

• 00841036150525: SP-1885
• 00841036132262: SP-1883
• 00841036127725: SP-1884
• 00841036125073: SP-1886
• 00841036282769: SP-2101
• 00841036282752: SP-2100
• 00841036282745: SP-2098
• 00841036282738: SP-2097
• 00841036282554: SP-1840
• 00841036282547: SP-1819
• 00841036282516: SP-1807
• 00841036282509: SP-1806
• 00841036199760: SP-1927
• 00841036199753: SP-1926
• 00841036199692: SP-1851
• 00841036199685: SP-1850
• 00841036198114: SP-1832
• 00841036198107: SP-1831
• 00841036158866: SP-1819
• 00841036143671: SP-1880
• 00841036142827: SP-1879
• 00841036136512: SP-1838
• 00841036136321: SP-1928
• 00841036136314: SP-1929
• 00841036134600: SP-1806
• 00841036132019: 20-1100-12
• 00841036131456: 15-1100-12
• 00841036131043: SP-2087
• 00841036129910: SP-1841
• 00841036129798: SP-1830
• 00841036125752: SP-2101
• 00841036125745: SP-2102
• 00841036125738: SP-2104
• 00841036125721: SP-2096
• 00841036125714: SP-2099
• 00841036125707: SP-2097
• 00841036125691: SP-2100
• 00841036125684: SP-2098
• 00841036125677: SP-2103
• 00841036125660: SP-2105
• 00841036125479: SP-1840
• 00841036125196: SP-1807
• 00841036124687: SP-1842
• 00841036123543: SP-2090
• 00841036122980: SP-2082
• 00841036082246: SP-1408
• 00841036076122: 15-2401
• 00841036069629: 20-1100-13
• 00841036069612: 15-1100-13
• 00841036032470: 15-2400