INTEGRAL CENTRALIZER HIP SYSTEM 12-162613

GUDID 00880304223318

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304223318
• NIH Device Record Key: 3dbe4fe3-d0c7-4229-916e-44953bf06409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRAL CENTRALIZER HIP SYSTEM
• Version Model Number: 12-162613
• Catalog Number: 12-162613
• 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	00880304223318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942479

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [INTEGRAL CENTRALIZER HIP SYSTEM]

• 00880304223356: 12-162617
• 00880304223332: 12-162615
• 00880304223318: 12-162613
• 00880304223295: 12-162611
• 00880304223271: 12-162609
• 00880304208728: 11-162717
• 00880304208711: 11-162715
• 00880304208681: 11-162711
• 00880304208667: 11-162709
• 00880304001121: 11-162713