MISI-Medical Imaging Solutions International

FDA UDI

Class II (US FDA UDI)

by Canadian Hospital Specialties Limited

Identity

Trade Name: MISI-Medical Imaging Solutions International FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: MR Angiographic Syringe. 1-65ml Syringe , 1-115ml Syringe, 1-Large Spike, 1- Small Spike, 1-96" T Coiled Tubing with Check Valve FDA UDI
Model / Reference: 100302T FDA UDI
Description: MR Angiographic Syringe. 1-65ml Syringe , 1-115ml Syringe, 1-Large Spike, 1- Small Spike, 1-96" T Coiled Tubing with Check Valve FDA UDI

Identifiers

Catalog Number: 100302T FDA UDI
Primary DI / UDI-DI: 00628725095097 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Angiographic syringe FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Angiographic syringe

MISI-Medical Imaging Solutions International by Canadian Hospital Specialties Limited — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Canadian Hospital Specialties Limited

Sources (1)

FDA UDI 6bfe6e4a-dd2f-4048-9f9b-c9f94605c5dd 35 fields · synced May 30, 2026