BIO-CLAD ALL POLY CUP SYSTEM 163485

GUDID 00880304256026

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304256026
• NIH Device Record Key: a15670c6-b640-45a0-b119-ece31c0e350d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-CLAD ALL POLY CUP SYSTEM
• Version Model Number: 163485
• Catalog Number: 163485
• 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	00880304256026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K770219

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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: 2019-05-22
• Device Publish Date: 2015-10-24

On-Brand Devices [BIO-CLAD ALL POLY CUP SYSTEM]

• 00880304256118: 163497
• 00880304256101: 163496
• 00880304256095: 163495
• 00880304256088: 163494
• 00880304256071: 163493
• 00880304256064: 163492
• 00880304256057: 163491
• 00880304256040: 163487
• 00880304256033: 163486
• 00880304256026: 163485
• 00880304256019: 163484
• 00880304256002: 163483
• 00880304255999: 163482
• 00880304255982: 163481
• 00880304255975: 163478
• 00880304255968: 163477
• 00880304255951: 163476
• 00880304255944: 163475
• 00880304255920: 163471
• 00880304255913: 163468
• 00880304255906: 163467
• 00880304255890: 163466
• 00880304255883: 163465
• 00880304255869: 163464
• 00880304255845: 163463
• 00880304255838: 163462
• 00880304255821: 163461
• 00880304255814: 163454
• 00880304255791: 163453
• 00880304255784: 163452
• 00880304255777: 163451
• 00880304255760: 163446
• 00880304255753: 163445
• 00880304255739: 163443
• 00880304255722: 163442
• 00880304255715: 163441
• 00880304011076: 163472
• 00880304011069: 163474
• 00880304011052: 163473
• 00880304001626: 163444