FDA.reportPublic FDA data

EcoSonic

Primary DI
00620974003496
Brand
EcoSonic
Company
Southmedic Incorporated
Model
43394-04
Catalog number
43394-04
Device description
EcoSonic Descaler, 4G
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10620974003493PrimaryGS10
00620974003496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400349310620974003493
00620974003496006209740034966209740034960620974003496

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume4Gallon

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(705)726-9383custserv@southmedic.com

Regulatory Flags#

DUNS number
246848147
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10620974004483Southmedic Instrument Cleaning BrushesPK45601PK456012026-05-19
10620974004490Southmedic Instrument Cleaning BrushesPK456000PK4560002026-05-19
10620974004551Southmedic Instrument Cleaning BrushesPK45304NSPK45304NS2026-05-19
10620974004568Southmedic Instrument Cleaning BrushesPK45306PK453062026-05-19
10620974003349SPSS Safety Scalpel Metal Handle73-8041-173-8041-12023-02-07
10620974001338Southmedic Instrument Cleaning BrushesPK45DS01PK45DS012026-01-07
10620974004506Southmedic Instrument Cleaning BrushesPK45DS02PK45DS022026-01-07
10620974004513Southmedic Instrument Cleaning BrushesPK45DS03PK45DS032026-01-07
10620974004520Southmedic Instrument Cleaning BrushesPK45DS04PK45DS042026-01-07
10620974004537Southmedic Instrument Cleaning BrushesPK45DS05PK45DS052026-01-07
10620974004285BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
00620974004288BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
10620974002069BetterShield™MXFS-FOAMMXFS-FOAM2020-10-02
10620974002076BetterShield™MXFS-50-FOAMMXFS-50-FOAM2020-10-02
10620974002083BetterShield™MXFS-SAMPLEMXFS-SAMPLE2020-10-02
00620974002048BetterShield™MXFS-25MXFS-252020-10-02
10620974004322Southmedic Instrument Cleaning BrushesPK45602PK456022025-08-28
10620974004339Southmedic Instrument Cleaning BrushesPK45603PK456032025-08-28
10620974004346Southmedic Instrument Cleaning BrushesPK45604PK456042025-08-28
10620974004353Southmedic Instrument Cleaning BrushesPK45605PK456052025-08-28

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