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DeTACH - Detachable Aortic Cross Clamp Head - Small

FDA UDI

Class II (US FDA UDI)

by Biorep Technologies, Inc.

Identity

Trade Name
DeTACH - Detachable Aortic Cross Clamp Head - Small FDA UDI
Generic Name
Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI
Device Name
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 FDA UDI
Model / Reference
1.0 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
MI-XCHS-551 FDA UDI
Primary DI / UDI-DI
00858733006253 FDA UDI
510(k) Number
K210006 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Surgical soft-tissue manipulation forceps, scissors-like, single-use

DeTACH - Detachable Aortic Cross Clamp Head - Small by Biorep Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical soft-tissue manipulation forceps, scissors-like, single-use.

Cleared under the same submission

K210006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biorep Technologies, Inc.

Sources (1)

  • FDA UDI e0a31175-44e0-403d-a816-0137057f1c09 35 fields · synced May 30, 2026