BRANDMAX

GUDID 04961333244355

BRANDMAX TRI CLEAN ULTRASONIC CLEANER

PENTAX OF AMERICA, INC.

Non-submersible device disinfection chamber

• Primary Device ID: 04961333244355
• NIH Device Record Key: c295c360-d7be-4518-8744-98615da1b426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRANDMAX
• Version Model Number: U-5LH
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	04961333244355 [Primary]

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-03-15

Devices Manufactured by PENTAX OF AMERICA, INC.

• 04961333255016 - LARYNGOSTROBOSCOPE: 2025-05-05 LARYNGEAL STROBE 9500
• 04961333255702 - LARYNGOSTROBOSCOPE: 2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500"
• 04961333255719 - LARYNGOSTROBOSCOPE: 2025-05-05 9500MC, Lapel Microphone "Accessory for 9500"
• 04961333255726 - LARYNGOSTROBOSCOPE: 2025-05-05 9500FS, Footswitch "Accessory for 9500 "
• 00854924006255 - C2 CryoBalloon Ablation System: 2025-04-14 Gen 2 360 Degree Pear Catheter
• 00854924006293 - C2 CryoBalloon Ablation System: 2025-04-14 Gen 2 360 Degree Standard Catheter
• 04961333255313 - C2 CryoBalloon: 2024-09-20
• 04961333255320 - C2 CryoBalloon: 2024-09-20