AccessGUDID - DEVICE: ACIST Kodama® Coronary Imaging Catheter (10841716100755)

GUDID

Device Identifier (DI) Information

Brand Name: ACIST Kodama® Coronary Imaging Catheter
Version or Model: 017788
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACIST MEDICAL SYSTEMS, INC.

Primary DI Number: 10841716100755
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926684994 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBJ	Catheter, Ultrasound, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Frequency: 40/60 Mega HertZ
Device Size Text, specify: Imaging Profile: 3.2 French
Device Size Text, specify: Working Length: 142 Centimeter

Device Record Status

Public Device Record Key: 0a83a139-4e71-49cf-a4c9-92c6584f458a
Public Version Date: February 20, 2024
Public Version Number: 5
DI Record Publish Date: September 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30841716101213	5	10841716100755	2020-07-15	Not in Commercial Distribution	Shelf Box
20841716101438	5	10841716100755	2019-10-02	Not in Commercial Distribution	Shelf box
30841716101435	1	20841716101438	2019-10-02	Not in Commercial Distribution	Single Pack
30841716102289	5	10841716100755		In Commercial Distribution	Shelf Box