OTOMIMIX

GUDID 00841036141943

BIOMET MICROFIXATION, INC

Orthopaedic cement, non-medicated Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00841036141943
• NIH Device Record Key: fdf7023e-beb0-4383-92b3-5f2678c3bcf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOMIMIX
• Version Model Number: 7014-3266
• 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: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036141943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042516

FDA Product Code

• NEA: Cement, Ear, Nose And Throat

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-11

Devices Manufactured by BIOMET MICROFIXATION, INC

• 00888233069373 - Sternalock EZ, Box Junction Plate, 10 Holes: 2024-04-02
• 00888233069380 - Sternalock EZ, O Junction Plate, 12 Holes: 2024-04-02
• 00888233069434 - Sternalock EZ, O Plate, 6 Holes: 2024-04-02
• 00888233069441 - 18mm Locking Screw: 2024-04-02
• 00888233069458 - 14mm Locking Screw: 2024-04-02
• 00888233069595 - Sternalock EZ, V Plate, 4 Holes: 2024-04-02
• 00888233069601 - Sternalock EZ, H Plate, 6 Holes: 2024-04-02
• 00888233069618 - Sternalock EZ, V Junction Plate, 10 Holes: 2024-04-02