Model: IPNB00158
Catalog: VPS-G4SC
DI: 10801902225808
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
80515d99-ba7d-4c93-a1c1-d49780054ef8
Distribution Status:
In Commercial Distribution
DUNS Number:
002348191
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 - Pkg Type:
CS
Item #1 - Device ID:
20801902225805
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
40
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10801902225808
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10801902225808
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44141
Name: Intravascular ultrasound imaging catheter, single-use
Definition:
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.
FDA Product Codes
KKX
Drape, surgical
Premarket Submissions
Submission Number:
K101689
Supplement Number:
000