Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: GEN2 FDA UDI
Generic Name: Vaginal dilator FDA UDI
Device Name: Walther Dilator-Catheters 32 Fr Female, Overall Length 5-1/4" (13.3cm) FDA UDI
Model / Reference: G2OB1616 FDA UDI
Description: Walther Dilator-Catheters 32 Fr Female, Overall Length 5-1/4" (13.3cm) FDA UDI

Identifiers

Catalog Number: G2OB1616 FDA UDI
Primary DI / UDI-DI: 00840343721930 FDA UDI
FDA Product Code: HDQ FDA UDI
GMDN Term: Vaginal dilator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 5.25 Inch FDA UDI
Catheter Gauge — 32 French FDA UDI

Category: Vaginal dilator

Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ELMED INCORPORATED — ELMED INCORPORATED · Class I

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: Surgix Medical Llc

Sources (1)

FDA UDI 9539fd16-9727-43f4-b920-c7633cd0e537 36 fields · synced Jun 8, 2026