Model: A
Catalog: ACE501PTS
DI: 00884450809594
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0ecd2d89-d8da-4237-b3ce-ee539b92c5a7
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:
10884450809591
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450809594
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450809594
Item #2 - Device ID Type:
Primary
Item #2 - 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
DRE
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Device Sizes
Item #1 - Size Text:
Needle Gauge (G)-21G
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Introducer Length (cm)-10 cm (4")
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Guide Wire Diameter (OD)-0.018" (0.46 mm)
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Introducer French Size (F)-5F
Item #4 - Size Type:
Device Size Text, specify