OPTIVAC KIT, 40 GRAM SINGLE MIX 417100

GUDID 00880304370579

BIOMET

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 00880304370579
• NIH Device Record Key: 181fcf37-a9dc-4e6b-8cc1-47f112dc7148
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIVAC KIT, 40 GRAM SINGLE MIX
• Version Model Number: 417100
• Catalog Number: 417100
• Company DUNS: 260930126
• Company Name: BIOMET
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.com
• Phone: +0330475759100
• Email: eufrvra@zimmerbiomet.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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304370579 [Primary]

FDA Product Code

• JDZ: MIXER, CEMENT, FOR CLINICAL USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-09

Devices Manufactured by BIOMET

• 07350023771719 - Cement Delivery System: 2021-05-05
• 03599870107898 - TESS BASE: 2020-10-21
• 03599870108505 - T.E.S.S® LID: 2020-10-21
• 08428898898332 - TESS BOTTOM INSERT HEMI: 2020-10-21
• 08428898898349 - TESS TOP INSERT HEMI: 2020-10-21
• 70880304810999 - Cement Delivery System: 2020-04-23
• 07350023771092 - Optivac Nozzle Slim: 2019-10-21
• 00887868214578 - BIOMET® BONE CEMENT R: 2018-07-06