Identity
- Trade Name
- DeTACH Aortic Cross Clamp Quick Release Device FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, scissors-like, reusable 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 utilizes the DeTACH Quick Release. 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 utilizes the DeTACH Quick Release. FDA UDI
Identifiers
- Catalog Number
- MI-XCQR-001 FDA UDI
- Primary DI / UDI-DI
- 00858733006291 FDA UDI
- 510(k) Number
- K210006 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, scissors-like, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable
DeTACH Aortic Cross Clamp Quick Release Device by Biorep Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210006 also covers:
- DeTACH - Detachable Aortic Cross Clamp Head - Large — BIOREP TECHNOLOGIES, INC.
- DeTACH - Detachable Aortic Cross Clamp Head - Medium — BIOREP TECHNOLOGIES, INC.
- DeTACH - Detachable Aortic Cross Clamp Head - Small — BIOREP TECHNOLOGIES, INC.
- DeTACH Aortic Cross Clamp Delivery Device — BIOREP TECHNOLOGIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biorep Technologies, Inc.
Sources (1)
- FDA UDI 8af30a03-8df5-4ba8-aa65-6ee4aed22b61 35 fields · synced Jun 8, 2026