Model: B
Catalog: 1623-F820M
DI: 00884450766958
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
29c3d01e-1c13-4708-99a4-3a4936654155
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
Device ID:
00884450766958
Type:
Primary
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:
Recommended Guide Wire-0.035" (0.89 mm)
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Length-70 cm
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
French Size (F)-4F
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Internal Diameter-0.041" (1.04 mm)
Item #4 - Size Type:
Device Size Text, specify