HEALEY HIP SYSTEM 11-105470

GUDID 00880304201293

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304201293
• NIH Device Record Key: 536c2576-af9e-4c1c-92dc-3ff227321412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALEY HIP SYSTEM
• Version Model Number: 11-105470
• Catalog Number: 11-105470
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304201293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921139

FDA Product Code

• JDL: Prosthesis, hip, semi-constrained (metal cemented acetabular component)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-03-25

On-Brand Devices [HEALEY HIP SYSTEM]

• 00880304201132: 11-105448
• 00880304201293: 11-105470
• 00880304201286: 11-105468
• 00880304201279: 11-105466
• 00880304201262: 11-105464
• 00880304201255: 11-105462
• 00880304201248: 11-105460
• 00880304201231: 11-105458
• 00880304201217: 11-105456
• 00880304201194: 11-105454
• 00880304201170: 11-105452
• 00880304201156: 11-105450