DFS STANDARD FIXATOR SYSTEM 01430

GUDID 00880304497023

Biomet Orthopedics, LLC

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

• Primary Device ID: 00880304497023
• NIH Device Record Key: 03f30688-1aff-4029-9235-3583c5a141ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS STANDARD FIXATOR SYSTEM
• Version Model Number: 01430
• Catalog Number: 01430
• 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	00880304497023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081244
• Premarket Notification: K953406

FDA Product Code

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

Sterilization

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

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

Moist Heat or Steam Sterilization

[00880304497023]

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 STANDARD FIXATOR SYSTEM]

• 00880304529120: 01185
• 00880304506046: 01515
• 00880304497023: 01430
• 00880304494879: 01300
• 00880304492912: 01000
• 00880304491748: 01400
• 00880304491724: 01350
• 00888480103202: 01710
• 00888480103103: 01540
• 00888480102663: 01175
• 00888480102595: 01155
• 00888480102427: 01110
• 00888480100331: 01001
• 00887868081026: 01550
• 00887868081002: 01530
• 00887868080999: 01525
• 00887868080982: 01520
• 00887868080968: 01505
• 00887868080951: 01500
• 00887868080944: 01460
• 00887868080920: 01450
• 00887868080913: 01435
• 00887868080852: 01250
• 00887868080821: 01200
• 00887868080807: 01180
• 00887868080784: 01165
• 00887868080777: 01160
• 00887868080746: 01140
• 00887868080739: 01135
• 00887868080722: 01130
• 00887868080715: 01120
• 00887868080708: 01115
• 00887868080678: 01090
• 00887868080661: 01085
• 00887868080647: 01070
• 00887868080609: 01040
• 00887868080593: 01030
• 00887868080579: 01010
• 00888480420026: 90115
• 00888480420019: 90110