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

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• Primary Device ID: 05060171914532
• NIH Device Record Key: 161df7fc-b8c5-4dce-901e-bfd623b4a52f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tristel ULT
• Version Model Number: 45-25 (case of 2 boxes)
• Company DUNS: 235192791
• Company Name: TRISTEL SOLUTIONS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171914532 [Package]; Contains: 05060171914679; Package: Case [2 Units]; In Commercial Distribution
GS1	05060171914679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220041

FDA Product Code

• QWS: Foam Or Gel Chemical Sterilant/High Level Disinfectant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Tristel ULT]

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