DeTACH - Detachable Aortic Cross Clamp Head - Large MI-XCHL-851

GUDID 00858733006246

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.

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

• Primary Device ID: 00858733006246
• NIH Device Record Key: 9600443f-d116-40e4-8f30-11c2bdade9bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeTACH - Detachable Aortic Cross Clamp Head - Large
• Version Model Number: 1.0
• Catalog Number: MI-XCHL-851
• Company DUNS: 073724333
• Company Name: Biorep Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858733006239 [Primary]
GS1	00858733006246 [Package]; Contains: 00858733006239; Package: Shelf Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210006

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

[00858733006246]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

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