Arcos® Revision Hip Instrumentation 31-301910

GUDID 05019279431465

Biomet Uk Ltd

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 05019279431465
• NIH Device Record Key: a8444e4c-3fef-4b2b-965a-49c263467505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arcos® Revision Hip Instrumentation
• Version Model Number: 31-301910
• Catalog Number: 31-301910
• Company DUNS: 219322575
• Company Name: Biomet Uk Ltd
• 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: 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(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	05019279431465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100469

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

[05019279431465]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [Arcos® Revision Hip Instrumentation]

• 05019279431557: 31-301920
• 05019279431533: 31-301919
• 05019279432691: 31-301902
• 05019279431564: 31-301921
• 05019279431526: 31-301918
• 05019279431502: 31-301913
• 05019279431496: 31-301912
• 05019279431472: 31-301911
• 05019279431465: 31-301910
• 05019279430475: 31-301901