Equinoxe 314-06-24

GUDID 10885862228321

Exactech, Inc.

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 10885862228321
• NIH Device Record Key: 71dc9506-78c1-4700-b59b-3af7abd2c268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinoxe
• Version Model Number: 314-06-24
• Catalog Number: 314-06-24
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862228321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121220

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2015-10-30