MI DeTACH - Aortic Cross Clamp - Delivery System Kit

Basic Information

• Brand Name: MI DeTACH - Aortic Cross Clamp - Delivery System Kit
• Primary DI: 00858733006321
• Version / Model: 1.0
• Catalog Number: MI-XCDS-001
• Company Name: Biorep Technologies, Inc.
• Labeler DUNS: 073724333
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-17
• Public Version: 1
• Public Version Date: 2021-12-27
• Public Version Status: New
• Public Device Record Key: d5ddc099-578b-404a-af99-24e2d7e681cd

Device Description

The DeTACH Delivery System is a reusable delivery and retrieval system for the DeTACH Detachable Aortic Cross Clamp Head device. The kit includes the Delivery Device, Quick Release Device, and Sterilization Tray.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

GMDN Terms

Code	Name	Definition	Implantable	Status
46409	Cardiothoracic surgical procedure kit, non-medicated, reusable	A collection of various sterile cardiothoracic surgical instruments dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This device is reusable after appropriate cleaning/sterilization of the instruments/reusable products, and when the consumable/pharmaceutical products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858733006321	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]