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 FDA UDI
- Model / Reference
- HV-2001 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 FDA UDI
Identifiers
- Catalog Number
- HV-2001 FDA UDI
- Primary DI / UDI-DI
- 00085003717902 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
- Not 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
USB HV Heart Retractor Set by USB Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8afd678c-a427-4e48-88c0-93a4bccf27c8 35 fields · synced May 30, 2026