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Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED INCORPORATED FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
RICHARDS T-Tube inserter, stainless steel, shaft Ø 1.2 mm, working length 3 3/4” (9.5 cm) FDA UDI
Model / Reference
36-39195 FDA UDI
Description
RICHARDS T-Tube inserter, stainless steel, shaft Ø 1.2 mm, working length 3 3/4” (9.5 cm) FDA UDI

Identifiers

Catalog Number
36-39195 FDA UDI
Primary DI / UDI-DI
00198506085147 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, reusable 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: ENT surgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as ENT surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 2623284b-51cd-4a29-a924-88bfcf95c041 35 fields · synced Jun 7, 2026