RINGLOC RANAWAT / BURSTEIN HIP SYSTEM 106054

GUDID 00880304010451

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304010451
• NIH Device Record Key: 4d35d825-e4ad-44b4-a282-205f75494a55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RINGLOC RANAWAT / BURSTEIN HIP SYSTEM
• Version Model Number: 106054
• Catalog Number: 106054
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304010451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050124

FDA Product Code

• MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

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: 2019-05-15
• Device Publish Date: 2015-10-24

On-Brand Devices [RINGLOC RANAWAT / BURSTEIN HIP SYSTEM]

• 00880304203389: 11-106080
• 00880304203372: 11-106078
• 00880304203365: 11-106076
• 00880304203358: 11-106074
• 00880304203341: 11-106072
• 00880304203334: 11-106070
• 00880304203327: 11-106068
• 00880304203310: 11-106066
• 00880304203303: 11-106064
• 00880304203297: 11-106062
• 00880304203280: 11-106058
• 00880304203266: 11-106056
• 00880304203242: 11-106054
• 00880304203235: 11-106052
• 00880304203211: 11-106048
• 00880304203204: 11-106046
• 00880304203198: 11-106044
• 00880304203181: 11-106042
• 00880304203174: 11-106040
• 00880304194540: 106042
• 00880304194533: 106040
• 00880304010468: 106070
• 00880304010451: 106054
• 00880304010444: 106064
• 00880304010437: 106072
• 00880304010420: 106052
• 00880304010413: 106048
• 00880304010406: 106050
• 00880304010390: 106046
• 00880304010383: 106074
• 00880304010376: 106076
• 00880304010369: 106080
• 00880304010048: 11-106060
• 00880304008373: 106066
• 00880304008359: 106060
• 00880304007642: 106058
• 00880304001541: 106056
• 00880304001527: 106062
• 00880304001510: 11-106050
• 00880304001503: 106044
• 00880304000612: 106078
• 00880304000582: 106068