Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Vascular graft tunneller FDA UDI
Device Name: VASCULAR TUNNELER SET, INCLUDES: ROD HANDLE, 60CM LONG ROD, 50CM SHORT ROD, 11MM BULLET TIP, 8.5MM BULLET TIP, 11MM X 58CM SHEATH, 11MM X 49CM SHEATH, 8.5MM X 49CM SHEATH FDA UDI
Model / Reference: 24-PVT1000 FDA UDI
Description: VASCULAR TUNNELER SET, INCLUDES: ROD HANDLE, 60CM LONG ROD, 50CM SHORT ROD, 11MM BULLET TIP, 8.5MM BULLET TIP, 11MM X 58CM SHEATH, 11MM X 49CM SHEATH, 8.5MM X 49CM SHEATH FDA UDI

Identifiers

Catalog Number: 24-PVT1000 FDA UDI
Primary DI / UDI-DI: 00842180185807 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Vascular graft tunneller 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: Vascular graft tunneller

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 12fd8286-a0c2-48d0-9bae-088a68f9327e 35 fields · synced May 31, 2026