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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Rigid endoscope telescope FDA UDI
Device Name
4MM, 30 DEG., VIEWING, ELMED EOS-HD PREMIUM SINUS SCOPE WITH STORZ TYPE SLEESE LOCK, PREMIUM GERMAN MADE OPTICAL LENS SYSTEM, STANDARD TYPE ACMI LIGHT POST WITH WOLF AND STORZ ADAPTERS, FULLY AUTOCLAVABLE. (130MM) FDA UDI
Model / Reference
37400-30 FDA UDI
Description
4MM, 30 DEG., VIEWING, ELMED EOS-HD PREMIUM SINUS SCOPE WITH STORZ TYPE SLEESE LOCK, PREMIUM GERMAN MADE OPTICAL LENS SYSTEM, STANDARD TYPE ACMI LIGHT POST WITH WOLF AND STORZ ADAPTERS, FULLY AUTOCLAVABLE. (130MM) FDA UDI

Identifiers

Catalog Number
37400-30 FDA UDI
Primary DI / UDI-DI
00842180187191 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Rigid endoscope telescope FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

Yes

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: Rigid endoscope telescope

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

Similar devices

Also classified as Rigid endoscope telescope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI dbf27a4a-4c05-4188-a436-d8009716dcee 35 fields · synced Jun 6, 2026