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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
8mm Sheath for Tunneler Stainless Steel 60 cm slight curved FDA UDI
Model / Reference
ST242296008 FDA UDI
Description
8mm Sheath for Tunneler Stainless Steel 60 cm slight curved FDA UDI

Identifiers

Catalog Number
ST242296008 FDA UDI
Primary DI / UDI-DI
00842180198494 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

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: Vascular graft tunneller

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

Similar devices

Also classified as Vascular graft tunneller.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 7e63d7ec-504d-496a-bf38-8168fe5b573a 35 fields · synced Jun 1, 2026