AccessGUDID - DEVICE: Tristel ULT (05060171914679)

GUDID

Device Identifier (DI) Information

Brand Name: Tristel ULT
Version or Model: 45-25 (case of 2 boxes)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRISTEL SOLUTIONS LIMITED

Primary DI Number: 05060171914679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 235192791 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 161df7fc-b8c5-4dce-901e-bfd623b4a52f
Public Version Date: October 24, 2023
Public Version Number: 1
DI Record Publish Date: October 16, 2023