HTR-PMI

GUDID 00888233037525

BIOMET MICROFIXATION, INC

Cranioplasty plate, non-alterable

• Primary Device ID: 00888233037525
• NIH Device Record Key: 29839342-717b-4ad9-b95e-bc91a49faeab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTR-PMI
• Version Model Number: PM624057
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233037525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924935

FDA Product Code

• KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-01
• Device Publish Date: 2021-03-24

On-Brand Devices [HTR-PMI]

• 00841036260682: PM620853
• 00841036258306: PM621023
• 00841036256708: PM621082
• 00841036256463: PM620866
• 00841036255633: PM621093
• 00841036255459: PM621166
• 00841036254988: PM621160
• 00841036253042: PM621025
• 00841036257903: PM621187
• 00841036257781: PM621204
• 00841036256777: PM621190
• 00841036256432: PM621213
• 00841036256227: PM621172
• 00841036256166: PM621214-A
• 00841036256159: PM621205-A
• 00841036256142: PM621188
• 00841036255985: PM621208
• 00841036255831: PM621203
• 00841036255725: PM621194
• 00841036255640: PM621186
• 00841036255626: PM621200
• 00841036255619: PM621182
• 00841036255558: PM621202
• 00841036255541: PM621167-A
• 00841036255466: PM621181
• 00841036255442: PM621189
• 00841036255183: PM621170
• 00841036255176: PM621171
• 00841036255169: PM621173
• 00841036255053: PM621169
• 00841036255046: PM621168
• 00841036260712: PM621248
• 00841036260071: PM621265-B
• 00841036259648: PM621226-A
• 00841036258870: PM621226
• 00841036257699: PM621216-A
• 00841036257682: PM621242
• 00841036257675: PM621250
• 00841036257569: PM621227-A
• 00841036257552: PM621260
• 00841036257521: PM621241-A
• 00841036257446: PM621241
• 00841036257439: PM621262
• 00841036256852: PM621243
• 00841036256371: PM621267
• 00841036256364: PM621251
• 00841036256333: PM621252-B
• 00841036256234: PM621232-A
• 00841036256173: PM621249
• 00841036256135: PM621255