RINGLOC® HIP SYSTEM 105424

GUDID 00887868230028

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00887868230028
• NIH Device Record Key: 4dc4a2ac-14ab-4ba1-b041-9199942d5c49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RINGLOC® HIP SYSTEM
• Version Model Number: 105424
• Catalog Number: 105424
• 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	00887868230028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-17

On-Brand Devices [RINGLOC® HIP SYSTEM]

• 00887868343223: XL-195238
• 00887868343216: XL-195237
• 00887868343209: XL-195236
• 00887868343193: XL-195235
• 00887868343186: XL-195234
• 00887868343087: XL-106998
• 00887868343070: XL-106997
• 00887868343063: XL-106996
• 00887868343056: XL-106995
• 00887868343049: XL-106988
• 00887868343032: XL-106987
• 00887868343025: XL-106986
• 00887868343018: XL-106985
• 00887868342837: 12-105998
• 00887868342820: 12-105997
• 00887868342813: 12-105996
• 00887868342806: 12-105995
• 00887868342790: 12-105994
• 00887868359361: 11-105900
• 00887868348020: EP-156233
• 00887868348013: EP-155232
• 00887868348006: EP-105951
• 00887868347993: EP-105790
• 00887868347986: EP-105780
• 00887868230066: 105428
• 00887868230059: 105427
• 00887868230042: 105426
• 00887868230035: 105425
• 00887868230028: 105424
• 00887868230011: 105423
• 00887868230004: 105422
• 00887868229992: 105421
• 00887868229985: 105420