DFS® Adult Rail 06390

GUDID 00887868357879

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868357879
• NIH Device Record Key: 028321b6-f733-41e9-89f9-5e5731102165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS® Adult Rail
• Version Model Number: 06390
• Catalog Number: 06390
• 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	00887868357879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000083

FDA Product Code

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

Sterilization

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

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

Moist Heat or Steam Sterilization

[00887868357879]

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® Adult Rail]

• 00887868357916: 06420
• 00887868357909: 06410
• 00887868357893: 06400
• 00887868357886: 06395
• 00887868357879: 06390
• 00887868357862: 06385
• 00887868357855: 06380
• 00887868357848: 06375
• 00887868357831: 06370
• 00887868357824: 06360
• 00887868357817: 06350
• 00887868357800: 06345
• 00887868357794: 06342
• 00887868357787: 06330
• 00887868357770: 06320
• 00887868357763: 06316
• 00887868357756: 06315
• 00887868357749: 06311
• 00887868357732: 06310
• 00887868357725: 06306
• 00887868357718: 06305
• 00887868357701: 06301
• 00887868357695: 06300
• 00887868357688: 06262
• 00887868357671: 06260
• 00887868357664: 06255
• 00887868357657: 06250
• 00887868357640: 06140