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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Pulmonary dilator FDA UDI
Device Name
Single Ended Hegar Dilator, 32mm Tip, Autoclavable Medical Grade Stainless Steel FDA UDI
Model / Reference
71410-32 FDA UDI
Description
Single Ended Hegar Dilator, 32mm Tip, Autoclavable Medical Grade Stainless Steel FDA UDI

Identifiers

Catalog Number
71410-32 FDA UDI
Primary DI / UDI-DI
00842180170322 FDA UDI
FDA Product Code
HDQ FDA UDI
GMDN Term
Pulmonary 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pulmonary dilator

Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary dilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI d17ff7d0-ee2d-4f2d-874e-0f863fa62457 35 fields · synced May 30, 2026