VANGUARD 360 REVISION REAMERS 591204

GUDID 00880304532540

Biomet Orthopedics, LLC

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00880304532540
• NIH Device Record Key: 8e3bccdc-f2ea-4ed7-a87c-03bf7db297b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD 360 REVISION REAMERS
• Version Model Number: 591204
• Catalog Number: 591204
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304532540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093293

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

[00880304532540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11