Identity
- Trade Name
- Control 5F Mechanical Thrombectomy System 135cm FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. FDA UDI
- Model / Reference
- A5-135 FDA UDI
- Description
- The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. FDA UDI
Identifiers
- Catalog Number
- A5-135 FDA UDI
- Primary DI / UDI-DI
- B090A51350 FDA UDI
- FDA Product Code
- QEZ FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose syringe, single-useThrombectomy suction catheter
Control 5F Mechanical Thrombectomy System 135cm by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e1c3033b-8117-4695-aab4-8e3f4848bab3 34 fields · synced May 30, 2026