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AngioTouch® Kit

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
AngioTouch® Kit FDA UDI
Generic Name
Contrast medium injection system hand controller kit FDA UDI
Device Name
Model AT X65L FDA UDI
Model / Reference
019499 FDA UDI
Description
Model AT X65L FDA UDI

Identifiers

Primary DI / UDI-DI
10841716103251 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Contrast medium injection system hand controller kit 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Contrast medium injection system hand controller kit

AngioTouch® Kit by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Contrast medium injection system hand controller kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACIST Medical Systems, Inc.

Sources (1)

  • FDA UDI 88cdccc2-ee91-46b3-bdb8-4635670e2743 33 fields · synced Jun 8, 2026