Bi-Metric® Revision Hip System 162346

GUDID 00887868261350

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00887868261350
• NIH Device Record Key: db0eab99-15d0-49fb-b95e-24cbc2fb9f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Metric® Revision Hip System
• Version Model Number: 162346
• Catalog Number: 162346
• 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	00887868261350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

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 [Bi-Metric® Revision Hip System]

• 00887868261589: 162369
• 00887868261572: 162368
• 00887868261565: 162367
• 00887868261558: 162366
• 00887868261541: 162365
• 00887868261534: 162364
• 00887868261527: 162363
• 00887868261510: 162362
• 00887868261503: 162361
• 00887868261497: 162360
• 00887868261480: 162359
• 00887868261473: 162358
• 00887868261466: 162357
• 00887868261459: 162356
• 00887868261442: 162355
• 00887868261435: 162354
• 00887868261428: 162353
• 00887868261411: 162352
• 00887868261404: 162351
• 00887868261398: 162350
• 00887868261381: 162349
• 00887868261374: 162348
• 00887868261367: 162347
• 00887868261350: 162346
• 00887868261343: 162345
• 00887868261336: 162344
• 00887868261329: 162343
• 00887868261312: 162342
• 00887868261305: 162341
• 00887868261299: 162340