FDA.reportPublic FDA data

GuruNanda Ultrasonic Aligner Cleaning Pod

Primary DI
00810051089530
Brand
GuruNanda Ultrasonic Aligner Cleaning Pod
Company
Gurunanda, LLC
Model
GN08953
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051089530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051089530008100510895308100510895300810051089530

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic-cleaning water bathAn electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079671169
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810051088649GuruNanda Aligner and Denture Cleaning FoamGNF1292026-04-29
00810051089004GuruNandaGNF1352026-01-28
00810051089479GuruNandaGNF1352026-01-28
00810051088458GuruNanda Water Flosser H3200A H3200A2025-06-27
00810051081787GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
00810051083415GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGNF022025-05-06
00810051086515GuruNanda Water Flosser R3100AR3100A 4.02025-04-02
00810051086843GuruNanda Kids Water FlosserRK1002025-04-02
00810051087048GuruNanda Compact Water Flosser, HM100HM1002025-04-02
00810051087055GuruNanda Compact Water Flosser,HM1002025-04-02
00810051087109GuruNanda Professional Whitening Wireless Kit1.02025-04-01
00810051086317GuruNanda Compact Water Flosser HM100HM1002025-02-26
00810051084702GuruNanda Steel Sonic TB - Rose Gold5500A2024-03-13
00810051084719GuruNanda Steel Sonic TB - Gold5500A2024-03-13
00810051084726GuruNanda Steel Sonic TB - Teal5500A2024-03-13
00810051084764GuruNanda Rotary Toothbrush - Lavederi20002024-03-13
00810051084771GuruNanda Rotary Toothbrush - Lavederi20002024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218864PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218848PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218855PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
00724995231057ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231064ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231071ProlysticaSTERIS CORPORATIONFLG2026-01-14
10705037018062ENZOL™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018130CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018161CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
D661UC300230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
H816GEL121Spec Clean Pre Treatment GelMicroCare, LLCFLG2025-10-23
H816OP1281OptizymeMicroCare, LLCFLG2025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsMicroCare, LLCFLG2025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalineMicroCare, LLCFLG2025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PLR32Spec Clean Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW050Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW128Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZF128Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PREZF240Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PRR050Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PRR128Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PVAC128Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22