RingLoc® Hip System XL-106988

GUDID 00887868343049

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00887868343049
• NIH Device Record Key: a78a111b-c413-419c-b213-ec6ee62d2a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RingLoc® Hip System
• Version Model Number: XL-106988
• Catalog Number: XL-106988
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868343049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062997

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

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