OptionELITE Vena Cava Filter

FDA UDI

Class II (US FDA UDI)

by Rex Medical LLP

Identity

Trade Name: OptionELITE Vena Cava Filter FDA UDI
Generic Name: Vena cava filter, temporary/permanent FDA UDI
Model / Reference: 352506070E FDA UDI

Identifiers

Catalog Number: 352506070E FDA UDI
Primary DI / UDI-DI: 00857141005001 FDA UDI
FDA Product Code: DTK FDA UDI
GMDN Term: Vena cava filter, temporary/permanent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Vena cava filter, temporary/permanent

OptionELITE Vena Cava Filter by Rex Medical LLP — 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: Rex Medical LLP

Sources (1)

FDA UDI 4ad33f4c-15a7-4e69-ade8-852343f28acc 34 fields · synced May 31, 2026