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MI DeTACH - Aortic Cross Clamp - Delivery System Kit
FDA UDIIdentity
- Trade Name
- MI DeTACH - Aortic Cross Clamp - Delivery System Kit FDA UDI
- Generic Name
- Cardiothoracic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MI-XCDS-001 FDA UDI
- Primary DI / UDI-DI
- 00858733006321 FDA UDI
- GMDN Term
- Cardiothoracic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- 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
Yes
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: Cardiothoracic surgical procedure kit, non-medicated, reusable
MI DeTACH - Aortic Cross Clamp - Delivery System Kit by Biorep Technologies, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiothoracic surgical procedure kit, non-medicated, reusable.
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- V. Mueller — STERIS CORPORATION · Class I
- V. Mueller — STERIS CORPORATION · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Biorep Technologies, Inc.
Sources (1)
- FDA UDI d5ddc099-578b-404a-af99-24e2d7e681cd 35 fields · synced Jun 8, 2026