Identity
- Trade Name
- USB HV Heart Retractor Set FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Re-usable heart retractor for use in minimally invasive surgical procedures contains: HVR-H1 - Handle, HVR-B3 Blade 40mm with Hinge, HVR-B6 Blade 50mm with Hinge, HVR-X1 Hex Screwdriver, DF-101 Delivery Forceps, Large Sterilization Tray FDA UDI
- Model / Reference
- HV-2002 FDA UDI
- Description
- Re-usable heart retractor for use in minimally invasive surgical procedures contains: HVR-H1 - Handle, HVR-B3 Blade 40mm with Hinge, HVR-B6 Blade 50mm with Hinge, HVR-X1 Hex Screwdriver, DF-101 Delivery Forceps, Large Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- HV-2002 FDA UDI
- Primary DI / UDI-DI
- 00850037179442 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held surgical retractor, reusable
USB HV Heart Retractor Set by USB Medical, Ltd. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- USB Medical, Ltd.
Sources (1)
- FDA UDI f192d1b4-04b7-4fb7-801f-02ba6c1fd827 34 fields · synced Jun 1, 2026