ACE-FISCHER®OLIVE WIRE 10419

GUDID 00887868001482

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868001482
• NIH Device Record Key: 30043555-ef28-4aeb-bfcb-b64c299240b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE-FISCHER®OLIVE WIRE
• Version Model Number: 10419
• Catalog Number: 10419
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 3
• 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	00887868001482 [Primary]
GS1	70887868001481 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895079

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

Moist Heat or Steam Sterilization

[00887868001482]

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 [ACE-FISCHER®OLIVE WIRE]

• 00887868010767: 1042-01-001
• 00887868001499: 10420
• 00887868001482: 10419