HUMERAL ENDCAP, FLUSH 800301001

GUDID 00887868031441

Biomet Orthopedics, LLC

Bone nail end-cap, sterile Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap

• Primary Device ID: 00887868031441
• NIH Device Record Key: 8ee1a26c-4331-4dce-9541-2a8360d4d8d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMERAL ENDCAP, FLUSH
• Version Model Number: 8003-01-001
• Catalog Number: 800301001
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868031441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934643

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2015-10-24

On-Brand Devices [HUMERAL ENDCAP, FLUSH]

• 00887868000577: 1720
• 00887868031441: 8003-01-001