Gynex

FDA UDI

Class I (US FDA UDI)

by Gynex Corporation

Identity

Trade Name: Gynex FDA UDI
Generic Name: Vaginal speculum, reusable FDA UDI
Model / Reference: 2525 FDA UDI

Identifiers

Primary DI / UDI-DI: GYNX25250 FDA UDI
FDA Product Code: HDF FDA UDI
GMDN Term: Vaginal speculum, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4520 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vaginal speculum, reusable

Gynex by Gynex Corporation — 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: Gynex Corporation

Sources (1)

FDA UDI 6f59ffaf-9d1a-459b-99c9-221a12ab270c 32 fields · synced May 31, 2026