CANNULATED HEXALOBULAR DRIVER AO 110008449

GUDID 00887868109652

Biomet Orthopedics, LLC

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• Primary Device ID: 00887868109652
• NIH Device Record Key: b6e9ec1b-9cf4-4b64-aef1-6970cb02784e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULATED HEXALOBULAR DRIVER AO
• Version Model Number: 110008449
• Catalog Number: 110008449
• 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: false
• 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
• 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 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	00887868109652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140891
• Premarket Notification: K143188

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

Moist Heat or Steam Sterilization

[00887868109652]

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: 2016-09-26

On-Brand Devices [CANNULATED HEXALOBULAR DRIVER AO]

• 00887868109676: 110008453
• 00887868109669: 110008451
• 00887868109652: 110008449