Medical Imaging Solutions Intl.

FDA UDI

Class II (US FDA UDI)

by Medical Imaging Solutions International Company

Identity

Trade Name: Medical Imaging Solutions Intl. FDA UDI
Generic Name: Angiographic syringe FDA UDI
Device Name: 1-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike UM FDA UDI
Model / Reference: 200301A FDA UDI
Description: 1-60ml syringes, 1-96" Y coiled tubing, check valve, 1 large spike UM FDA UDI

Identifiers

Primary DI / UDI-DI: 00850014500177 FDA UDI
510(k) Number: K170279 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Angiographic syringe

Medical Imaging Solutions Intl. by Medical Imaging Solutions International Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Angiographic syringe.

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NAMIC — MEDLINE INDUSTRIES, INC. · Class II
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Inject8™ — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K170279 also covers:

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 Imaging Solutions International Company

Sources (1)

FDA UDI d1e420e0-1dd1-4b4c-b436-2ebf51493eb6 34 fields · synced May 30, 2026