STERNALOCK BLU SYSTEM SP-2891

GUDID 00841036155391

BIOMET MICROFIXATION, INC

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

• Primary Device ID: 00841036155391
• NIH Device Record Key: c647e8bb-5b56-40b8-a672-c579c26813b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERNALOCK BLU SYSTEM
• Version Model Number: SP-2891
• Catalog Number: SP-2891
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036155391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110574

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

Moist Heat or Steam Sterilization

[00841036155391]

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 [STERNALOCK BLU SYSTEM]

• 00841036216511: SP-3323
• 00841036184476: SP-3192
• 00841036184469: SP-3191
• 00841036183141: SP-3184
• 00841036183134: SP-3185
• 00841036179519: SP-3143
• 00841036170257: SP-3052
• 00841036216498: SP-3321
• 00841036203696: SP-3261
• 00841036196059: SP-3245
• 00841036182502: SP-3188
• 00841036177072: SP-3142
• 00841036170080: SP-3040
• 00841036169848: SP-3037
• 00841036169763: SP-3055
• 00841036158651: SP-2914
• 00841036158644: SP-2913
• 00841036155391: SP-2891
• 00888233017619: SP-3192
• 00888233017596: SP-3191