Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED INCORPORATED FDA UDI
Generic Name: Urethral dilator, reusable FDA UDI
Device Name: Cannulated Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, 18Fr. Autoclavable Medical Grade Stainless Steel. FDA UDI
Model / Reference: ST31400018C FDA UDI
Description: Cannulated Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, 18Fr. Autoclavable Medical Grade Stainless Steel. FDA UDI

Identifiers

Catalog Number: ST31400018C FDA UDI
Primary DI / UDI-DI: 00198506085307 FDA UDI
FDA Product Code: HDQ FDA UDI
GMDN Term: Urethral dilator, reusable 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Urethral dilator, reusable

Elmed Incorporated by Elmed Incorporated — 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: Elmed Incorporated

Sources (1)

FDA UDI f9d25781-2338-4768-847f-e58c4a12511d 35 fields · synced May 30, 2026