DFS® Mini Fixator 07000

GUDID 00887868358128

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: 00887868358128
• NIH Device Record Key: f5cd1042-0aa8-46fe-8c25-1798a787d102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS® Mini Fixator
• Version Model Number: 07000
• Catalog Number: 07000
• 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	00887868358128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970290

FDA Product Code

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

Sterilization

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

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

Moist Heat or Steam Sterilization

[00887868358128]

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® Mini Fixator]

• 00887868358210: 07060
• 00887868358203: 07055
• 00887868358180: 07040
• 00887868358142: 07020
• 00887868358135: 07010
• 00887868358128: 07000