Vascu-Sheath®

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name: VASCU-SHEATH® FDA UDI
Generic Name: Vascular catheter introduction needle FDA UDI
Device Name: 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIRE & 22GA SAFETY NEEDLESAFETY NEEDLE FDA UDI
Model / Reference: DMR1902622S FDA UDI
Description: 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIRE & 22GA SAFETY NEEDLESAFETY NEEDLE FDA UDI

Identifiers

Catalog Number: DMR1902622S FDA UDI
Primary DI / UDI-DI: 00884908144390 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Vascular catheter introduction needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular catheter introduction needle

Vascu-Sheath® by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cook — COOK INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II
BD Potts-Cournand 18Gx2.05in — BECTON DICKINSON AND COMPANY · Class II
Procedure Products needles — PROCEDURE PRODUCTS, INC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Medical Components Inc

Sources (1)

FDA UDI d18f7c20-5284-4a37-bb02-5dd5a03c393d 35 fields · synced Jun 8, 2026