OMNIMAX 99-5924

GUDID 00841036274696

BIOMET MICROFIXATION, INC

Orthopaedic bone wire

• Primary Device ID: 00841036274696
• NIH Device Record Key: abf309bd-375a-4ba7-b1ac-47a9d4285933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNIMAX
• Version Model Number: 99-5924
• Catalog Number: 99-5924
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036274696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831005

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00841036274696]

Moist Heat or Steam Sterilization

[00841036274696]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-15
• Device Publish Date: 2019-10-07

On-Brand Devices [OMNIMAX]

• 00841036274719: 01-5824
• 00841036274702: 99-5824
• 00841036274696: 99-5924
• 00841036274689: 01-5924