PECTUS BLU (TM) 78-6115

GUDID 00888233032643

BIOMET MICROFIXATION, INC

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• Primary Device ID: 00888233032643
• NIH Device Record Key: 65606da1-6683-46d0-930a-c4ce7bcd1fc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PECTUS BLU (TM)
• Version Model Number: 78-6115
• Catalog Number: 78-6115
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233032643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212841

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

[00888233032643]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [PECTUS BLU (TM)]

• 00888233037860: 78-0070
• 00888233032858: 78-8040
• 00888233032834: 78-8020
• 00888233032759: 78-6170
• 00888233032742: 78-6165
• 00888233032735: 78-6160
• 00888233032728: 78-6155
• 00888233032711: 78-6150
• 00888233032704: 78-6145
• 00888233032698: 78-6140
• 00888233032681: 78-6135
• 00888233032674: 78-6130
• 00888233032667: 78-6125
• 00888233032650: 78-6120
• 00888233032643: 78-6115
• 00888233032636: 78-6110
• 00888233032629: 78-6105
• 00888233032612: 78-6100
• 00888233032605: 78-6095
• 00888233032599: 78-6090
• 00888233032582: 78-6085
• 00888233032575: 78-6080
• 00888233032568: 78-6075
• 00888233032551: 78-6070
• 00888233028950: 78-5001
• 00888233028943: 78-5000
• 00888233028868: 78-0060
• 00888233028851: 78-0051
• 00888233028844: 78-0050
• 00888233028837: 78-0040
• 00888233028813: 78-0030
• 00888233028806: 78-0020
• 00888233028790: 78-0012
• 00888233028783: 78-0011
• 00888233028776: 78-0010