FDA.reportPublic FDA data

DeTACH - Detachable Aortic Cross Clamp Head - Small

Primary DI
00858733006307
Brand
DeTACH - Detachable Aortic Cross Clamp Head - Small
Company
Biorep Technologies, Inc.
Model
1.0
Catalog number
MI-XCHS-551
Device description
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
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210006000MI DeTACHBiorep Technologies, Inc.2021-03-04DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858733006307PackageGS16In Commercial Distribution
00858733006253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858733006307008587330063078587330063070858733006307
00858733006253008587330062538587330062530858733006253

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, single-useA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
073724333
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
10381780142935Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142942Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
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10381780143123Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14