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Control 10T Mechanical Thrombectomy System Tubing, 3-Pack
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Control 10T Mechanical Thrombectomy System Tubing, 3-Pack FDA UDI
- Generic Name
- Thrombectomy tubing set, non-electronic FDA UDI
- Device Name
- The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” FDA UDI
- Model / Reference
- MT10-100-3 FDA UDI
- Description
- The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” FDA UDI
Identifiers
- Catalog Number
- MT10-100-3 FDA UDI
- Primary DI / UDI-DI
- B090MT1010030 FDA UDI
- FDA Product Code
- BYY FDA UDI
- GMDN Term
- Thrombectomy tubing set, non-electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy tubing set, non-electronic
Control 10T Mechanical Thrombectomy System Tubing, 3-Pack by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Thrombectomy tubing set, non-electronic.
- Control 10T Mechanical Thrombectomy Filter — ZIEN Medical Technologies, LLC · Class II
- Control 10T Mechanical Thrombectomy System Tubing, Female Suction — ZIEN Medical Technologies, LLC · Class II
- Control 10T Mechanical Thrombectomy System Tubing, Female Suction — ZIEN Medical Technologies, LLC · Class II
- Control 10T Mechanical Thrombectomy System Tubing — ZIEN Medical Technologies, LLC · Class II
- Control 10T Mechanical Thrombectomy Filter — ZIEN Medical Technologies, LLC · Class II
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
- ZIEN Medical Technologies, LLC
Sources (1)
- FDA UDI a5b38c37-45b8-443e-92eb-e8eebfd36180 34 fields · synced May 30, 2026