BIOREP TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005593675	3005593675	BIOREP TECHNOLOGIES, INC.	1	N	2026-01-01	15804 NW 57th Ave Miami Lakes FL US 33014

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00861361000234	Irrigation Syringe Attachment - The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings	3053304449	customerservice@biorep.com
00861361000241	Irrigation Syringe Attachment - The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings	3053304449	customerservice@biorep.com

biorep.com

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
125437	1698819201
125437	1773277421
125437	2057880769

GUDID#

DeTACH - Detachable Aortic Cross Clamp Head - Large - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-23
DeTACH - Detachable Aortic Cross Clamp Head - Small - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH DetachableAortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-22
DeTACH - Detachable Aortic Cross Clamp Head - Medium - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH DetachableAortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-23
DeTACH Aortic Cross Clamp Delivery Device - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-23
DeTACH Aortic Cross Clamp Quick Release Device - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Quick Release.
Biorep Technologies, Inc.
2024-04-23
Irrigation Syringe Attachment - The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings
Biorep Technologies, Inc.
2025-02-14
Irrigation Syringe Attachment - The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings
Biorep Technologies, Inc.
2025-02-14
JOSEPH LAMELAS Knot Pusher - The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity.
Biorep Technologies, Inc.
2024-04-23
JOSEPH LAMELAS Atrial Lift System - The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.
Biorep Technologies, Inc.
2024-04-23
MI CUFF - Aortic Root Exposure Device - The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.
Biorep Technologies, Inc.
2024-04-23
COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle - The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.
Biorep Technologies, Inc.
2024-04-23
SUTURE BELT - Circumferential Suture Organizer - The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.
Biorep Technologies, Inc.
2024-04-23
JOSEPH LAMELAS Knot Pusher - The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracorporeal object contained within a small cavity.
Biorep Technologies, Inc.
2024-04-23
JOSEPH LAMELAS Atrial Lift System - The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.
Biorep Technologies, Inc.
2024-04-23
MI CUFF - Aortic Root Exposure Device - The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.
Biorep Technologies, Inc.
2024-04-23
COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle - The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.
Biorep Technologies, Inc.
2024-04-23
SUTURE BELT - Circumferential Suture Organizer - The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device incorporates a rigid base frame with 24 flexible holding plug inserts that receive and retain suture pairs. Suture retention is achieved by pressing the suture strands into the compression slots found between the rigid base frame and flexible holding plug inserts. The rigid base frame consists of 2 hinged halves which allow for angle adjustment of the individual segments. The attachment arms allow the device to be mounted to the retractor arms. Two spacer components allow the attachment arm height to be adjusted. The device is secured into the desired orientation and segment angle positioning by tightening the immobilizing thumb screws.
Biorep Technologies, Inc.
2024-04-23
Joseph Lamelas Intercostal Retractor System Rack - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System (IRS) 222 Small Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System (IRS) 222 Medium Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System (IRS) 222 Large Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System (IRS) 222 Extra Large Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
Joseph Lamelas Intercostal Retractor System - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
Joseph Lamelas Intercostal Retractor System (IRS) 222 Sterilization Tray - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System Small Double Swivel Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
MI Intercostal Retractor System Medium Double Swivel Blade Set - The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.
Biorep Technologies, Inc.
2024-04-23
DeTACH - Detachable Aortic Cross Clamp Head - Large - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-23
DeTACH - Detachable Aortic Cross Clamp Head - Medium - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-23
DeTACH - Detachable Aortic Cross Clamp Head - Small - The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device
Biorep Technologies, Inc.
2024-04-22
MI DeTACH - Aortic Cross Clamp - Delivery System Sterilization Tray - 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.
Biorep Technologies, Inc.
2021-12-17
MI DeTACH - Aortic Cross Clamp - Delivery System Kit - 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.
Biorep Technologies, Inc.
2021-12-17