DFS DISTAL RADIUS FIXATOR 04101

GUDID 00887868082337

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868082337
• NIH Device Record Key: f3867e55-d41c-45a7-9dd7-a37d9e84dacd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS DISTAL RADIUS FIXATOR
• Version Model Number: 04101
• Catalog Number: 04101
• 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	00887868082337 [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

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

Moist Heat or Steam Sterilization

[00887868082337]

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 [DFS DISTAL RADIUS FIXATOR]

• 00888480107392: 04310
• 00888480107231: 04115
• 00887868082375: 04170
• 00887868082351: 04103
• 00887868082337: 04101
• 00887868082290: 04056
• 00887868082214: 04000