DFS BONE SCREWS SD60-18060B

GUDID 00888480093961

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: 00888480093961
• NIH Device Record Key: 97ad1ae5-6c89-48a4-9a0f-d79b47f18a9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS BONE SCREWS
• Version Model Number: SD60-18060B
• Catalog Number: SD60-18060B
• 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	00888480093961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023399

FDA Product Code

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

Sterilization

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

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

Moist Heat or Steam Sterilization

[00888480093961]

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 BONE SCREWS]

• 00880304491243: A30-07020
• 00888480094012: SD60-25050
• 00888480093961: SD60-18060B
• 00888480093879: SD50-25050
• 00888480093640: SD40-14040B
• 00888480093619: SD40-12040
• 00888480093572: SD40-12020
• 00888480093558: SD40-10040
• 00888480093534: SD40-10030
• 00888480093275: SD30-08020
• 00888480000792: A60-11040T
• 00887868130908: B60-15070
• 00887868105388: A30-08030
• 00887868105357: SD60-25080
• 00887868105340: SD60-20070B
• 00887868105333: SD60-20070
• 00887868105326: SD60-18060
• 00887868105319: SD60-15050
• 00887868105289: SD50-25080
• 00887868105272: SD50-20080B
• 00887868105265: SD50-20080
• 00887868105258: SD50-18050B
• 00887868105241: SD50-18050
• 00887868105234: SD50-15050B
• 00887868105227: SD50-15050
• 00887868105210: SD50-12030B
• 00887868105203: SD40-20040B
• 00887868105180: SD40-17040
• 00887868105173: SD50-12030
• 00887868105098: SD40-08035B
• 00887868105081: SD40-14040
• 00887868105074: SD40-07020
• 00887868105050: SD40-08020
• 00887868105036: SD30-08035
• 00887868104558: SD30-07020
• 00887868103223: B60-20090
• 00887868103209: B60-18090
• 00887868103193: B60-20080
• 00887868103186: B60-17080
• 00887868103179: B60-16090
• 00887868103162: B60-18010
• 00887868103155: B60-16070
• 00887868103148: B60-15060
• 00887868103131: B60-14050
• 00887868103124: B60-15080
• 00887868103117: B60-13060
• 00887868103100: B60-13040
• 00887868103094: B60-13050
• 00887868103087: B60-12060
• 00887868103070: B60-11050