DFS® XS Rail 04426

GUDID 00887868357565

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: 00887868357565
• NIH Device Record Key: 66d056ce-734d-40a6-bf0d-23682aca1d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS® XS Rail
• Version Model Number: 04426
• Catalog Number: 04426
• 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 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	00887868357565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010437

FDA Product Code

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

Sterilization

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

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

Moist Heat or Steam Sterilization

[00887868357565]

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® XS Rail]

• 00887868357633: 04495
• 00887868357626: 04485
• 00887868357619: 04475
• 00887868357602: 04465
• 00887868357596: 04455
• 00887868357589: 04445
• 00887868357572: 04440
• 00887868357565: 04426
• 00887868357558: 04421
• 00887868357541: 04416
• 00887868357534: 04411
• 00887868357527: 04410