THINFLAP SP-2046

GUDID 00888233014267

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: 00888233014267
• NIH Device Record Key: 3c68d8cd-b772-46ba-933f-924a2126f2a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THINFLAP
• Version Model Number: SP-2046
• Catalog Number: SP-2046
• 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	00888233014267 [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

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

Moist Heat or Steam Sterilization

[00888233014267]

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: 2020-06-16

On-Brand Devices [THINFLAP]

• 00841036282639: SP-1941
• 00841036199616: SP-1680
• 00841036133405: SP-2046
• 00841036131067: SP-1943
• 00841036130428: SP-1941
• 00841036130374: SP-1942
• 00841036079857: 19-1030
• 00841036079840: 19-1010
• 00841036079833: 19-1005
• 00841036079826: 19-1020
• 00841036079628: 19-1015
• 00841036079604: 19-1025
• 00888233014267: SP-2046
• 00888233014076: SP-1943
• 00888233014069: SP-1942