DFS MINI EXTERNAL FIXATION SYSTEM M16-07015

GUDID 00887868104459

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868104459
• NIH Device Record Key: d0df5fb1-4c5f-4f56-8970-8cb5ef63f2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS MINI EXTERNAL FIXATION SYSTEM
• Version Model Number: M16-07015
• Catalog Number: M16-07015
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 4
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868104459 [Primary]
GS1	70887868104458 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081244
• 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

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

Moist Heat or Steam Sterilization

[00887868104459]

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 MINI EXTERNAL FIXATION SYSTEM]

• 00887868104565: M30-07030T
• 00887868104541: M30-07025T
• 00887868104534: M30-07020T
• 00887868104527: M30-06025T
• 00887868104510: M30-06020T
• 00887868104503: M30-05018T
• 00887868104497: M25-04520T
• 00887868104480: M25-04015T
• 00887868104466: M30-06030T
• 00887868104459: M16-07015