DEVICE: Tristel ULT (05060171914679)
Device Identifier (DI) Information
Tristel ULT
45-25 (case of 2 boxes)
In Commercial Distribution
TRISTEL SOLUTIONS LIMITED
45-25 (case of 2 boxes)
In Commercial Distribution
TRISTEL SOLUTIONS LIMITED
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47631 | Medical device disinfection agent |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
DEN220041 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
161df7fc-b8c5-4dce-901e-bfd623b4a52f
October 24, 2023
1
October 16, 2023
October 24, 2023
1
October 16, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05060171914532 | 2 | 05060171914679 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined