DeTACH Aortic Cross Clamp Head-Small
Basic Information
- Brand Name
- DeTACH Aortic Cross Clamp Head-Small
- Primary DI
- 08022057015907
- Version / Model
- MI-XCHS-551
- Catalog Number
- MI-XCHS-551
- Company Name
- CORCYM SRL
- Labeler DUNS
- 441454802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-03
- Public Version
- 1
- Public Version Date
- 2026-02-11
- Public Version Status
- New
- Public Device Record Key
- 8311ab13-9248-4eb7-851a-e533b0a51e7d
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18022057015904 | GS1 | SHELF BOX | 6 | In Commercial Distribution | |
| Primary | 08022057015907 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210006 | 000 |