Echo® Bi-Metric® Hip System 192013

GUDID 00887868260445

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00887868260445
• NIH Device Record Key: de4f2919-ad72-457c-908b-a7db4e7033e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo® Bi-Metric® Hip System
• Version Model Number: 192013
• Catalog Number: 192013
• 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	00887868260445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070274

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-07-23

On-Brand Devices [Echo® Bi-Metric® Hip System]

• 00887868274046: 192521
• 00887868274039: 192520
• 00887868274022: 192519
• 00887868274015: 192518
• 00887868274008: 192517
• 00887868273995: 192516
• 00887868273988: 192515
• 00887868273971: 192514
• 00887868273964: 192513
• 00887868273957: 192512
• 00887868273940: 192511
• 00887868273933: 192510
• 00887868273926: 192509
• 00887868273919: 192508
• 00887868273902: 192421
• 00887868273896: 192420
• 00887868273889: 192419
• 00887868260797: 192418
• 00887868260780: 192417
• 00887868260773: 192416
• 00887868260766: 192415
• 00887868260759: 192414
• 00887868260742: 192413
• 00887868260735: 192412
• 00887868260728: 192411
• 00887868260711: 192410
• 00887868260704: 192409
• 00887868260698: 192408
• 00887868260681: 192407
• 00887868260674: 192121
• 00887868260667: 192120
• 00887868260650: 192119
• 00887868260643: 192118
• 00887868260636: 192117
• 00887868260629: 192116
• 00887868260612: 192115
• 00887868260605: 192114
• 00887868260599: 192113
• 00887868260582: 192112
• 00887868260575: 192111
• 00887868260568: 192110
• 00887868260551: 192109
• 00887868260544: 192108
• 00887868260537: 192107
• 00887868260520: 192021
• 00887868260513: 192020
• 00887868260506: 192019
• 00887868260490: 192018
• 00887868260483: 192017
• 00887868260476: 192016