Tristel OPH

GUDID 05060171915713

Tristel OPH is a high level disinfectant foam intended to disinfect cleaned, reusable ophthalmic devices. Supplied as a dual compartment Tristel OPH Foam bottle, a tub of Tristel OPH Wipes and a User Guide.

TRISTEL SOLUTIONS LIMITED

Medical device disinfection agent

• Primary Device ID: 05060171915713
• NIH Device Record Key: ab5d524a-08fc-46a7-a850-d96710aff479
• Commercial Distribution Discontinuation: 2025-07-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tristel OPH
• Version Model Number: TSL025126 (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	05060171915713 [Package]; Contains: 05060171915720; Package: Case [2 Units]; Discontinued: 2025-07-17; Not in Commercial Distribution
GS1	05060171915720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242732

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: 2025-07-25
• Device Publish Date: 2025-07-17

On-Brand Devices [Tristel OPH]

• 05060171915744: Tristel OPH Foam is ONLY to be used with Tristel OPH Wipes in Tristel OPH. Tristel OPH is a hig
• 05060171915713: Tristel OPH is a high level disinfectant foam intended to disinfect cleaned, reusable ophthalmic
• 05060171915706: Tristel OPH Wipes, to ONLY be used with Tristel OPH Foam. Tristel OPH is a high level disinfect