DISTAL RADIUS COMPLETE SYSTEM 04010

GUDID 00887868082238

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00887868082238
• NIH Device Record Key: d74c38fd-6f61-4120-b537-b7540e81632c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTAL RADIUS COMPLETE SYSTEM
• Version Model Number: 04010
• Catalog Number: 04010
• 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: 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(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	00887868082238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951357

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

[00887868082238]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [DISTAL RADIUS COMPLETE SYSTEM]

• 00888480106630: 04065
• 00888480106531: 04030
• 00887868082344: 04102
• 00887868082320: 04100
• 00887868082313: 04070
• 00887868082283: 04055
• 00887868082276: 04050
• 00887868082269: 04040
• 00887868082245: 04020
• 00887868082238: 04010