Tristel ULT

Primary DI
05060171914532
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235192791
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05060171914679Tristel ULT45-25 (case of 2 boxes)2023-10-16
05060171914549Tristel ULTTristel ULT Foam2023-10-16
05060171914556Tristel ULTTristel ULT Wipes2023-10-16

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
05060171914679Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914549Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914556Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16