Biorep Technologies, Inc.

Address:15804 NW 57th Ave,Miami Lakes,FL,33014,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instruments, Surgical, Cardiovascular (DWS) (1)

Premarket Exempt

No Yes

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MI DeTACH - Aortic Cross Clamp - Delivery System Sterilization Tray - 00858733006277 Catalog Number : MI-XC-T-001

Device Description : The Sterilization Tray is comprised of a lid and a base component. The steriliza The Sterilization Tray is comprised of a lid and a base component. The sterilization tray base has been preconfigured with receiving slots for the Delivery Device and Quick Release Device accessory components.

Device Class : 1

Duns Number: 073724333

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

MI DeTACH - Aortic Cross Clamp - Delivery System Kit - 00858733006321 Catalog Number : MI-XCDS-001

Device Description : The DeTACH Delivery System is a reusable delivery and retrieval system for the D 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 Class :

Duns Number: 073724333

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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