USB Deluxe HV Heart Retractor Set

FDA UDI

Class I (US FDA UDI)

by USB Medical, Ltd.

Identity

Trade Name: USB Deluxe HV Heart Retractor Set FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: Re-usable blades used with the HV heart retractor for use in minimally invasive surgical procedures contains: DF-101 Delivery Forceps, 4 each Mitral Blades & HVR-T2 Large Sterilization Tray FDA UDI
Model / Reference: HVB-J Set FDA UDI
Description: Re-usable blades used with the HV heart retractor for use in minimally invasive surgical procedures contains: DF-101 Delivery Forceps, 4 each Mitral Blades & HVR-T2 Large Sterilization Tray FDA UDI

Identifiers

Catalog Number: HVB-J Set FDA UDI
Primary DI / UDI-DI: 00850037179732 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable

USB Deluxe 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 31485b80-41c0-495f-a2cf-71dd5c201a68 34 fields · synced May 31, 2026