SteadySheath® Shortie LR-TSS-SH-11.0

GUDID 10884450441807

Merit Medical Systems, Inc.

Fascial tissue dilator, single-use
Primary Device ID10884450441807
NIH Device Record Keye3dce166-aeb9-43a4-bd1a-633fee4b675f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteadySheath® Shortie
Version Model NumberB
Catalog NumberLR-TSS-SH-11.0
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450441800 [Primary]
GS110884450441807 [Package]
Contains: 00884450441800
Package: [36 Units]
In Commercial Distribution

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-16
Device Publish Date2026-03-06

Devices Manufactured by Merit Medical Systems, Inc.

20884450029668 - Merit Medical®2026-03-20
10884450376451 - Merit Medical®2026-03-20
20884450423190 - Merit Medical®2026-03-20
20884450431270 - Merit Medical®2026-03-20
20884450431300 - Merit Medical®2026-03-20
10884450431365 - Merit Medical®2026-03-20
10884450433802 - Merit Medical®2026-03-20
10884450435363 - Merit Medical®2026-03-20

Trademark Results [SteadySheath]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STEADYSHEATH
STEADYSHEATH
85596078 4422644 Live/Registered
Cook Medical Technologies LLC
2012-04-12

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.