Identity
- Trade Name
- HV Heart Retractor Blade FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- HV Heart Retractor Blade / Paddle 40mm x Extended Hinge FDA UDI
- Model / Reference
- HVR-B34 FDA UDI
- Description
- HV Heart Retractor Blade / Paddle 40mm x Extended Hinge FDA UDI
Identifiers
- Catalog Number
- HVR-B34 FDA UDI
- Primary DI / UDI-DI
- 00085003717933 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
HV Heart Retractor Blade 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 b01913d0-a3ac-43b9-822e-06313eda1ecd 35 fields · synced May 30, 2026