FDA.reportPublic FDA data

MI DeTACH - Aortic Cross Clamp - Delivery System Kit

Primary DI
00858733006321
Brand
MI DeTACH - Aortic Cross Clamp - Delivery System Kit
Company
Biorep Technologies, Inc.
Model
1.0
Catalog number
MI-XCDS-001
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.
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858733006321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858733006321008587330063218587330063210858733006321

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
305-330-4449customerservice@biorep.com

Regulatory Flags#

DUNS number
073724333
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858733006239DeTACH - Detachable Aortic Cross Clamp Head - Large1.0MI-XCHL-8512024-04-23
00858733006253DeTACH - Detachable Aortic Cross Clamp Head - Small1.0MI-XCHS-5512024-04-22
00858733006345DeTACH - Detachable Aortic Cross Clamp Head - Medium1.0MI-XCHM-6512024-04-23
00858733006284DeTACH Aortic Cross Clamp Delivery Device1.0MI-XCDD-0012024-04-23
00858733006291DeTACH Aortic Cross Clamp Quick Release Device1.0MI-XCQR-0012024-04-23
00861361000234Irrigation Syringe Attachment1.0ISA-0012025-02-14
00861361000241Irrigation Syringe Attachment1.0ISA-0012025-02-14
00858733006000JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
00858733006017JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
00858733006024MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
00858733006031COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
00858733006048SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-0012024-04-23
10858733006007JOSEPH LAMELAS Knot Pusher8.0MI-KP-0012024-04-23
10858733006014JOSEPH LAMELAS Atrial Lift System10.0MI-ALS-0012024-04-23
10858733006021MI CUFF - Aortic Root Exposure Device4.0MI-CUFF-0012024-04-23
10858733006038COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle7.0MI-COTIE-0012024-04-23
10858733006045SUTURE BELT - Circumferential Suture Organizer9.0MI-ISBA-0012024-04-23
00858733006062Joseph Lamelas Intercostal Retractor System Rack5.0MI-IRS-R-0012024-04-23
00858733006086MI Intercostal Retractor System (IRS) 222 Small Blade Set3.0MI-IRS-SB-P012024-04-23
00858733006093MI Intercostal Retractor System (IRS) 222 Medium Blade Set3.0MI-IRS-MB-P012024-04-23