BioSonic

GUDID D661UC300

General Purpose Solution

COLTENE/WHALEDENT INC

Ultrasonic-cleaning water bath

• Primary Device ID: D661UC300
• NIH Device Record Key: 035b5525-761c-4135-b5a4-7e4b3e0b90c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSonic
• Version Model Number: UC30
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D661UC300 [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: 2023-09-18
• Device Publish Date: 2019-02-11

On-Brand Devices [BioSonic]

• D661600220470: UC150 Cleaner Unit JAP Plug Type AJ
• D661600219900: UC150 Cleaner Unit AUS Plug Type I
• D661600219890: UC150 Cleaner Unit UK Plug Type G
• D661600219880: UC150 Cleaner Unit Euro Plug Type F
• D661600219870: UC150 Cleaner Unit USA Plug Type A
• D661UCB20: Small Parts Basket
• D661UC960: UC95 Full Size Basket
• D661UC530: Borosilicate Beaker
• D661UC420: Germicidal Solution - 16 oz
• D661UC390: Cement Remover Solution
• D661UC380: Germicidal Solution - 8 oz
• D661UC3400: Replacement Cover
• D661UC340: Plaster and Stone Remover
• D661UC3351: 2 Basket Section Inserts
• D661UC3300: Two Beaker Holder
• D661UC3250: Cassette Basket
• D661UC320: Enzymatic Solution
• D661UC3151150: Remote Digital Timer - UC300R
• D661UC3110: Twin FingerGuard Basket
• D661UC3100: Large FingerGuard Basket
• D661UC300RB1150: UC300 Ultrasonic Cleaner, Recessed 115V
• D661UC300B1150: UC300 Ultrasonic Cleaner 115V
• D661UC300: General Purpose Solution
• D661UC155XD0: UC125 Accessory Kit
• D661UC1530: Single Beaker Holder
• D661UC152XD0: 3/4 FingerGuard Basket
• D661UC151XD0: Full Size FingerGuard Basket
• D661UC125B1150: UC125 Ultrasonic Cleaner 115V
• D661ST160: Soaking Tray
• D661600350620: UC150 Cleaner Unit USA Plug Type A - No Heater
• D661600220460: UC150 Sealing Gasket
• D661600220450: UC150 LID
• D661600220440: UC150 Drain Hose
• D661600220430: UC150 Drain Filter
• D661600220421: UC150 Accessory Kit
• D661600220410: UC150 Beaker Holder
• D661600220400: UC150 Casset Basket
• D661UC125LCD0: UC125LCD
• D661600196080: Suvi Scaler Tip - PE40HS
• D661600193280: Suvi Subgingival Nozzle
• D661600187660: Suvi Focus Group - Blue
• D661600187630: Suvi Focus Grip - Lime
• D661600184860: Suvi Angled Air Nozzle
• D661600184850: Suvi 90 Degree Air Nozzle
• D661600144570: Suvi Wrench for File Holders
• D661600144560: Suvi Torque Tip Wrench
• D661600144550: Suvi Universal Plastic Tip Wrench
• D661600144540: Suvi Universal Tip Wrench
• D661600143110: Suvi Scaler Tip - IH1
• D661600143090: Suvi Scaler Tip - FH2