HAART 301-00US

GUDID 10857160006314

HAART 301 Instrument Set (handles and sizers)

Corcym Inc.

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