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ACIST Kodama® Coronary Imaging Catheter

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name
ACIST Kodama® Coronary Imaging Catheter FDA UDI
Generic Name
Intravascular ultrasound imaging catheter, single-use FDA UDI
Device Name
Kodama Catheter, p/n 701470 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU FDA UDI
Model / Reference
017788 FDA UDI
Description
Kodama Catheter, p/n 701470 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU FDA UDI

Identifiers

Primary DI / UDI-DI
10841716100755 FDA UDI
FDA Product Code
OBJ FDA UDI
GMDN Term
Intravascular ultrasound imaging catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravascular ultrasound imaging catheter, single-use

ACIST Kodama® Coronary Imaging Catheter by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular ultrasound imaging catheter, single-use.

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 0a83a139-4e71-49cf-a4c9-92c6584f458a 34 fields · synced Jun 8, 2026