ACIST Kodama® Coronary Imaging Catheter

GUDID 10841716100755

Kodama Catheter, p/n 701470-001 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag, IFU

ACIST MEDICAL SYSTEMS, INC.

Intravascular ultrasound imaging catheter, single-use
Primary Device ID10841716100755
NIH Device Record Key0a83a139-4e71-49cf-a4c9-92c6584f458a
Commercial Distribution StatusIn Commercial Distribution
Brand NameACIST Kodama® Coronary Imaging Catheter
Version Model Number017788
Company DUNS926684994
Company NameACIST MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS110841716100755 [Primary]
GS120841716101438 [Package]
Package: Shelf box [5 Units]
In Commercial Distribution
GS130841716101213 [Package]
Package: Shelf Box [5 Units]
In Commercial Distribution
GS130841716101435 [Package]
Contains: 20841716101438
Package: Single Pack [1 Units]
In Commercial Distribution
GS130841716102289 [Package]
Package: Shelf Box [5 Units]
In Commercial Distribution

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-04
Device Publish Date2016-09-09

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

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