DFS XS RAIL 04421

GUDID 00887868082511

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868082511
• NIH Device Record Key: fe990241-25cc-4e09-b23c-7622307d9d23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS XS RAIL
• Version Model Number: 04421
• Catalog Number: 04421
• 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	00887868082511 [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

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

Moist Heat or Steam Sterilization

[00887868082511]

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 XS RAIL]

• 00887868082610: 04495
• 00887868082597: 04485
• 00887868082573: 04475
• 00887868082566: 04465
• 00887868082559: 04455
• 00887868082542: 04445
• 00887868082535: 04440
• 00887868082528: 04426
• 00887868082511: 04421
• 00887868082504: 04416
• 00887868082498: 04411
• 00887868082481: 04410