Cleaner, Ultrasonic, Medical Instrument

Product Code: FLG

General Hospital Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 880.6150


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsNo

Products Classified as FLG

2541Cleaner, Ultrasonic, Medical InstrumentUltrasonic Cleaner For Medical Instruments.

Total Product Life Cycle (TPLC) Devices

2541Cleaner, Ultrasonic, Medical InstrumentUltrasonic Cleaner For Medical Instruments.

Pre-market Notifications for FLG

K944950KLENZYMECALGON CORP.
K944494ALSA-KLENZCALGON VESTAL DIV.
K944033BILL EVANS-KLENZCALGON VESTAL DIV.
K941163MON-KLENZCALGON VESTAL DIV.
K940263NPH-KLENZCALGON CORP.
K935063INSTRU KLENZCALGON CORP.
K934666PDS ULTRACLEANMEDICAL POLYMERS, INC.
K933149INSTRUMENT DETERGENT CONCENTRATENOBELPHARMA USA, INC.
K931270SURGICLEAN ENZYMATIC INSTRUMENT CLEANERSURGICOT, INC.
K884660BIOSONIC ULTRASONIC CLEANING SYSTEMWHALEDENT INTL. DIV. IPCO
K861590WEC-KLEEN, CATALOG N. 850-102PALMETTO CHEMICAL & SUPPLY CO., INC.
K861592WEC-WASH, CATALOG NO. 850-115PALMETTO CHEMICAL & SUPPLY CO., INC.
K861588WECK INSTRUMENT CLEANER, CAT. NO. 850-103PALMETTO CHEMICAL & SUPPLY CO., INC.
K861587WECK CONCENTRATED LIQUID CLEANERPALMETTO CHEMICAL & SUPPLY CO., INC.
K861147UCS-2, ULTRASONIC CLEANING SOLUTIONKEYMED, INC.

Global Unique Device Identification Database

00841709105722Cleaner, ultrasonic, medical instrument
00841709105715Cleaner, ultrasonic, medical instrument
00841709105708Cleaner, ultrasonic, medical instrument
00841709105692Cleaner, ultrasonic, medical instrument
00841709105685Cleaner, ultrasonic, medical instrument
04961333244355Cleaner, Ultrasonic, Medical Instrument
04961333242740Cleaner, Ultrasonic, Medical Instrument
15019778000879Cleaner, Ultrasonic, Medical Instrument
00889813024201Cleaner, ultrasonic, medical instrument
00889813024188Cleaner, ultrasonic, medical instrument
D661600220470Cleaner, Ultrasonic, Medical Instrument
D661600219900Cleaner, Ultrasonic, Medical Instrument
D661600219890Cleaner, Ultrasonic, Medical Instrument
D661600219880Cleaner, Ultrasonic, Medical Instrument
D661600219870Cleaner, Ultrasonic, Medical Instrument

Maude Adverse Events

ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2019-09-11
ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2019-09-04
PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2019-08-28
RESURGE ULTRASONIC BATH 2.0 GALLONDENTSPLY LLC2019-08-08
AIRSENSE 10 AUTOSET USA TRIRESMED LTD2019-07-31
VALSURE ENZYMATIC CLEANERSTERIS CORPORATION2019-07-25
ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2019-07-05
INNOWAVE PCF SONIC IRRIGATORMEDISAFE UK LTD.2019-06-12
ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2018-11-09
CAVIWAVE PRO ULTRASONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2018-11-08
CAVIWAVE PRO ULTRASONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2018-10-17
PROLYSTICA HP NEUTRAL MANUAL CLEANERSTERIS CORPORATION2018-09-26
ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2018-09-17
CAVIWAVE ULTRASONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2018-08-01
ENDOSONIC CLEANER 220-240VKEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2018-07-04
CAVIWAVE ULTRA SONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2018-06-20
CAVIWAVE CONSOLE CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2018-06-14
PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2018-04-13
CAVIWAVE PRO ULTRASONIC CLEANING SYSTEMSTERIS CORPORATION - DISTRIBUTION CENTER2018-04-06
ENDOSONIC CLEANER 100V (OT)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2018-01-10
CAVIWAVE PRO ULTRASONIC CLEANING SYSTEMSTERIS CORPORATION - DISTRIBUTION CENTER2017-10-05
PRE-KLENZSTERIS CORPORATION2017-09-01
CAVIWAVE PRO ULTRASONIC CLEANING SYSTEMSTERIS CORPORATION - DISTRIBUTION CENTER2017-08-10
ENDOSONIC CLEANER 110-120V (OAI)KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.2017-07-14
HENRY SCHEIN SUPER CONCENTRATED GENERAL PURPOSEDENTSPLY PROFESSIONAL2017-04-12
PROLYSTICASTERIS CORPORATION2017-03-15
PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK & CLEANERSTERIS CORPORATION2017-02-23
SONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2017-01-06
PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2017-01-06
STERIS AMSCO SONIC BATHSTERIS2016-12-21
PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENTSTERIS CORPORATION2016-10-19
PATTERSON TARTAR & STAIN REMOVERHERAEUS KULZER, LLC2016-09-07
CLARISONICPACIFIC BIOSCIENCE LAB INC.2016-06-24
CAVIWAVE PRO ULTRASONICSTERIS CORPORATION - DISTRIBUTION CENTER2016-05-12
COLTENE/WHALEDENT INC.COLTENE/WHALEDENT INC.2016-03-28
PURIT ULTRASONIC TANKYOUNG DENTAL MANUFACTURING CO 1, LLC.2016-02-17
TARTAR AND STAIN REMOVERHERAEUS KULZER, LLC2016-02-03
CAVIWAVE PRO ULTRASONIC CONSOLESTERIS CORPORATION - DISTRIBUTION CENTER2016-01-29
CAVIWAVE ULTRASONIC CONSOLESTERIS CORPORATION - DISTRIBUTION CENTER2015-10-22
VALSURE NEUTRAL DETERGENTSTERIS CORPORATION2015-10-08
RELIANCE TABLETOP ULTRASONIC WASHERSTERIS CORPORATION - DISTRIBUTION CENTER2015-09-23
PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2015-07-08
CAVIWAVE PRO ULTRASONICSTERIS CORPORATION - DISTRIBUTION CENTER2015-06-26
VALSURE ENZYMATIC CLEANERSTERIS CORPORATION2015-06-22
CAVIWAVE PRO ULTRASONIC CLEANERSTERIS CORPORATION - DISTRIBUTION CENTER2015-06-10
PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2015-05-27
OLYMPUS ENDOSONIC ULTRASONIC CLEANERKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.2015-04-10
CREST ULTRASONIC CONSOLESTERIS CORPORATION - DISTRIBUTION CENTER2015-04-10
DRI-CLAVE VK4HERAEUS KULZER, LLC2015-04-01
PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANERSTERIS CORPORATION2015-03-06

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