TMS SYSTEM SP-2122

GUDID 00841036125967

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 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: 00841036125967
• NIH Device Record Key: 9ed59bb0-1191-4809-ae94-8af4ed31f676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMS SYSTEM
• Version Model Number: SP-2122
• Catalog Number: SP-2122
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036125967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980512

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

Moist Heat or Steam Sterilization

[00841036125967]

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 [TMS SYSTEM]

• 00841036126025: SP-2128
• 00841036126018: SP-2127
• 00841036126001: SP-2126
• 00841036125998: SP-2125
• 00841036125981: SP-2124
• 00841036125974: SP-2123
• 00841036125967: SP-2122
• 00841036125950: SP-2121
• 00841036125943: SP-2120
• 00841036125936: SP-2119
• 00841036125929: SP-2129
• 00841036125912: SP-2130
• 00841036089559: 20-6207
• 00841036089528: 25-2005
• 00841036089511: 25-2029
• 00841036089504: 25-2027
• 00841036089498: 25-2025
• 00841036089481: 25-2021
• 00841036089474: 25-2019
• 00841036089467: 25-2019T
• 00841036089450: 25-2017
• 00841036089443: 25-2015
• 00841036089436: 25-2013
• 00841036089429: 25-2011
• 00841036089412: 25-2009
• 00841036089405: 25-2007
• 00841036089399: 25-2004
• 00841036089382: 25-2317
• 00841036089375: 25-2315
• 00841036089368: 25-2309
• 00841036089351: 25-2307
• 00841036089344: 25-2305
• 00841036089320: 25-6205
• 00841036089313: 25-6204
• 00841036089306: 20-6205
• 00841036089290: 20-6204
• 00841036089221: 25-2023
• 00841036089214: 25-6207
• 00841036089207: 25-2311
• 00841036089191: 25-2313
• 00841036085414: 20-2317
• 00841036085407: 20-2315
• 00841036085391: 20-2313
• 00841036085384: 20-2311
• 00841036085377: 20-2309
• 00841036085360: 20-2307
• 00841036085353: 20-2305
• 00841036085339: 20-2029
• 00841036085322: 20-2027
• 00841036085315: 20-2025