DFS® Small Rail 06601

GUDID 00887868358036

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868358036
• NIH Device Record Key: f521574d-36f4-48b2-9827-d77d50c7d064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS® Small Rail
• Version Model Number: 06601
• Catalog Number: 06601
• 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	00887868358036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021031

FDA Product Code

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

Sterilization

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

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

Moist Heat or Steam Sterilization

[00887868358036]

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® Small Rail]

• 00887868358111: 06655
• 00887868358104: 06650
• 00887868358098: 06645
• 00887868358081: 06640
• 00887868358074: 06616
• 00887868358067: 06611
• 00887868358050: 06610
• 00887868358043: 06606
• 00887868358036: 06601
• 00887868358029: 06600
• 00887868358012: 06585
• 00887868358005: 06580
• 00887868357992: 06570
• 00887868357985: 06569
• 00887868357978: 06568
• 00887868357961: 06565
• 00887868357954: 06560
• 00887868357947: 06555
• 00887868357930: 06550
• 00887868357923: 06545