ACE ™TROCHANTERIC NAIL 903011235

GUDID 00887868064227

Biomet Orthopedics, LLC

Femur nail, non-sterile

• Primary Device ID: 00887868064227
• NIH Device Record Key: 716ba9d0-9dcf-4d8c-a15f-c12877cd1d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE ™TROCHANTERIC NAIL
• Version Model Number: 9030-11-235
• Catalog Number: 903011235
• 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	00887868064227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010780

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887868064227]

Moist Heat or Steam Sterilization

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 [ACE ™TROCHANTERIC NAIL]

• 00887868064463: 9032-13-135
• 00887868064456: 9032-13-130
• 00887868064449: 9032-13-125
• 00887868064401: 9032-11-135
• 00887868064395: 9032-11-130
• 00887868064388: 9032-11-125
• 00887868064258: 9030-13-235
• 00887868064241: 9030-13-230
• 00887868064234: 9030-13-225
• 00887868064227: 9030-11-235
• 00887868064210: 9030-11-230
• 00887868064203: 9030-11-225