HAART 301-00US

GUDID 10857160006314

HAART 301 Instrument Set (handles and sizers)

Corcym Inc.

Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable

• Primary Device ID: 10857160006314
• NIH Device Record Key: deebf6ef-cfac-4bd7-a0e9-b2473f114c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAART
• Version Model Number: 301-00US
• Catalog Number: 301-00US
• Company DUNS: 112833663
• Company Name: Corcym Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com
• Phone: 5129709112
• Email: julie.thomas@corcym.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10857160006314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163608

FDA Product Code

• DTI: Sizer, Heart-Valve, Prosthesis

Sterilization

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

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

[10857160006314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17