Tristel ULT

GUDID 05060171914532

Tristel ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumened ultrasound probes. Supplied as a dual compartment Tristel ULT Foam bottle, tub of Tristel ULT Wipes and a User Guide.

TRISTEL SOLUTIONS LIMITED

Medical device disinfection agent
Primary Device ID05060171914532
NIH Device Record Key161df7fc-b8c5-4dce-901e-bfd623b4a52f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTristel ULT
Version Model Number45-25 (case of 2 boxes)
Company DUNS235192791
Company NameTRISTEL SOLUTIONS LIMITED
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 Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS105060171914532 [Package]
Contains: 05060171914679
Package: Case [2 Units]
In Commercial Distribution
GS105060171914679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

On-Brand Devices [Tristel ULT]

05060171914532Tristel ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumen
05060171914556Tristel ULT Wipes, to ONLY be used with Tristel ULT Foam in Tristel ULT. Tristel ULT is a high l
05060171914549Tristel ULT Foam is ONLY to be used with Tristel ULT Wipes in Tristel ULT. Tristel ULT is a hig

Trademark Results [Tristel ULT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRISTEL ULT
TRISTEL ULT
79386516 not registered Live/Pending
Tristel Plc
2023-10-31

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