Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Body aspiration needle, reusable FDA UDI
Device Name: REUSABLE MEDIUM 45 DEG., ANGLE SHAFT WITH 3.75MM TIP RE-USABLE STAINLESS STEEL CORONARY PERFUSION CANNULA, 24CM OVERALL LENGTH, 3MM SUCTION TUBE O.D. 2MM, I.D TIP WITH 4 HOLES, FEMALE LUER LOCK FDA UDI
Model / Reference: 60-3501M FDA UDI
Description: REUSABLE MEDIUM 45 DEG., ANGLE SHAFT WITH 3.75MM TIP RE-USABLE STAINLESS STEEL CORONARY PERFUSION CANNULA, 24CM OVERALL LENGTH, 3MM SUCTION TUBE O.D. 2MM, I.D TIP WITH 4 HOLES, FEMALE LUER LOCK FDA UDI

Identifiers

Catalog Number: 60-3501M FDA UDI
Primary DI / UDI-DI: 00842180161313 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Body aspiration needle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Body aspiration needle, reusable

Elmed 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 9f46b43b-7f52-4449-a98b-3fbd767ca10a 35 fields · synced Jun 8, 2026