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Shockwave Medical IVL Generator and Connector Cable
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Shockwave Medical IVL Generator and Connector Cable FDA UDI
- Generic Name
- Ultrasound thrombolysis system control unit FDA UDI
- Device Name
- The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries. FDA UDI
- Model / Reference
- IVLGCCD FDA UDI
- Description
- The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries. FDA UDI
Identifiers
- Catalog Number
- IVLGCCD FDA UDI
- Primary DI / UDI-DI
- M732IVLGCCD0 FDA UDI
- FDA Product Code
- PPN FDA UDIQMG FDA UDI
- GMDN Term
- Ultrasound thrombolysis system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasound thrombolysis system control unit
Shockwave Medical IVL Generator and Connector Cable by Shockwave Medical, Inc. — 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
- Shockwave Medical, Inc.
Sources (1)
- FDA UDI cf0ebcf0-76d9-40fd-bf16-8fbdfcf1d5c9 36 fields · synced May 30, 2026