DFS® Distal Radius Fixator 04115

GUDID 00887868357404

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868357404
• NIH Device Record Key: 7cd12e34-b415-43ad-a5af-b1caa396cd8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS® Distal Radius Fixator
• Version Model Number: 04115
• Catalog Number: 04115
• 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	00887868357404 [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

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

[00887868357404]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [DFS® Distal Radius Fixator]

• 00887868357428: 04170
• 00887868357404: 04115
• 00887868357398: 04101
• 00887868357381: 04056