FDA UDI
In Commercial Distribution
🇺🇸 United States
DeTACH Aortic Cross Clamp Delivery System
DI: 08022057015914
·
Model: MI-XCDS-001
·
CORCYM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DeTACH Aortic Cross Clamp Delivery System
- Primary DI
- 08022057015914
- Version / Model
- MI-XCDS-001
- Catalog Number
- MI-XCDS-001
- 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
- 8070fcc5-6dbf-4fa8-bd78-7c46cadc1bb5
Device Description
The DeTACH Delivery System is a reusable delivery and retrieval system for the DeTACH Detachable Aortic Cross Clamp Head device. The kit includes the Delivery Device, Quick Release Device, and Sterilization Tray.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46409 | Cardiothoracic surgical procedure kit, non-medicated, reusable | A collection of various sterile cardiothoracic surgical instruments dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This device is reusable after appropriate cleaning/sterilization of the instruments/reusable products, and when the consumable/pharmaceutical products have been replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08022057015914 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210006 | 000 |