Tristel ULT

Primary DI
05060171914679
Brand
Tristel ULT
Company
TRISTEL SOLUTIONS LIMITED
Model
45-25 (case of 2 boxes)
Device description
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.
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWSFoam Or Gel Chemical Sterilant/High Level DisinfectantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220041000Tristel Duo ULTTristel Solutions Limited2023-06-02QWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171914532PackageGS12In Commercial Distribution
05060171914679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171914532050601719145325060171914532
05060171914679050601719146795060171914679

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Regulatory Flags#

DUNS number
235192791
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171915720Tristel OPHTSL025126 (case of 2 boxes)2025-07-17
05060171915706Tristel OPHTristel OPH Wipes2025-07-17
05060171915713Tristel OPHTSL025126 (case of 2 boxes)2025-07-17
05060171915744Tristel OPHTristel OPH Foam2025-07-17
05060171914686Tristel Test Strips45-132024-04-03
05060171914693Tristel Test Strips45-102024-04-03
05060171914549Tristel ULTTristel ULT Foam2023-10-16
05060171914556Tristel ULTTristel ULT Wipes2023-10-16
05060171914532Tristel ULT45-25 (case of 2 boxes)2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060171915720Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915706Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915713Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915744Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171914686Tristel Test StripsTRISTEL SOLUTIONS LIMITEDQWS2024-04-03
05060171914693Tristel Test StripsTRISTEL SOLUTIONS LIMITEDQWS2024-04-03
05060171914549Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914556Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914532Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16