BI-METRIC REVISION HIP SYSTEM 162360

GUDID 00880304252257

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00880304252257
• NIH Device Record Key: 6328fae7-bae8-41de-8624-7dde06b99538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-METRIC REVISION HIP SYSTEM
• Version Model Number: 162360
• Catalog Number: 162360
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304252257 [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: 2015-10-24

On-Brand Devices [BI-METRIC REVISION HIP SYSTEM]

• 00880304252288: 162369
• 00880304252271: 162368
• 00880304252264: 162361
• 00880304252257: 162360
• 00880304252240: 162359
• 00880304252233: 162357
• 00880304252226: 162356
• 00880304252202: 162355
• 00880304252196: 162354
• 00880304252103: 162340
• 00880304010758: 162350
• 00880304010741: 162351
• 00880304010734: 162358
• 00880304009912: 162344
• 00880304007819: 162353
• 00880304007161: 162364
• 00880304007017: 162349
• 00880304007000: 162348
• 00880304006997: 162343
• 00880304006980: 162366
• 00880304005686: 162346
• 00880304005679: 162347
• 00880304003798: 162367
• 00880304003521: 162365
• 00880304003514: 162363
• 00880304003507: 162362
• 00880304001138: 162341
• 00880304000278: 162352
• 00880304000261: 162342
• 00880304000254: 162345