Model: C
Catalog: 1628-017M
DI: 00884450787069
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7539ed70-05ed-40f8-96ac-98671e74c39e
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10884450787066
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450787069
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450787069
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 10688
Name: Angiographic catheter, single-use
Definition:
A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.
FDA Product Codes
DQO
Catheter, intravascular, diagnostic
Device Sizes
Item #1 - Size Text:
Label Long Description-CS VERTEBRAL
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
French Size (F)-5F
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Length-75 cm
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Recommended Guide Wire-0.038" (0.97 mm)
Item #4 - Size Type:
Device Size Text, specify