Model: J
Catalog: PHR5F11021SC
DI: 10884450118686
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7fa19b78-c0eb-47a6-9a7a-ee04cf220d27
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
5
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
20884450118683
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10884450118686
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10884450118686
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00884450118689
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 38128
Name: Vascular dilator, single-use
Definition:
A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.
FDA Product Codes
DYB
Introducer, catheter
Device Sizes
Item #1 - Size Text:
Needle Gauge (G)-21G
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Sheath French Size (F)-5F
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Sheath Length (cm)-11 cm (4.3")
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Guide Wire Diameter-0.021" (0.53 mm)
Item #4 - Size Type:
Device Size Text, specify