Model: B
Catalog: LR-TSS-SH-9.0
DI: 00884450441817
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c0ca3b5a-4147-4243-b1a7-62859878813f
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:
10884450441814
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
36
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450441817
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450441817
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 46448
Name: Fascial tissue dilator, single-use
Definition:
A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.
FDA Product Codes
DRE
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Device Sizes
Device Size - Size Text:
Sheath French Size (F)-9F
Device Size - Size Type:
Device Size Text, specify