FDA.reportPublic FDA data

HIP Cleaning Solution

Primary DI
07640397420406
Brand
HIP Cleaning Solution
Company
Dent4You AG
Model
CS-HIPL
Catalog number
CS-HIPL
Device description
HIP Cleaning Solution with Instrument Protection. For the Hydrim L110/M2.
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LDSDevice, Pasteurization, Hot Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDSDevice, Pasteurization, Hot WaterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17640397420403PackageGS12In Commercial Distribution
07540196001090PreviousGS10
07640397420406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1764039742040317640397420403
07540196001090075401960010907540196001090
07640397420406076403974204067640397420406

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.

Regulatory Flags#

DUNS number
480152811
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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07630243661237Alpen Diamonds60032031600320312026-09-04
07630243662470Alpen Diamonds60032155600321552026-09-04
07630243662494Alpen Diamonds60032157600321572026-09-04
07630243662517Alpen Diamonds60032159600321592026-09-04
07630243662531Alpen Diamonds60032161600321612026-09-04
07630243662555Alpen Diamonds60032163600321632026-09-04
07630243662579Alpen Diamonds60032165600321652026-09-04
07630243662593Alpen Diamonds60032167600321672026-09-04
07630243662616Alpen Diamonds60032169600321692026-09-04
07630243662630Alpen Diamonds60032171600321712026-09-04
07630243662654Alpen Diamonds60032173600321732026-09-04
07630243662678Alpen Diamonds60032175600321752026-09-04
07630243662692Alpen Diamonds60032177600321772026-09-04
07630243662715Alpen Diamonds60032179600321792026-09-04
07630243662739Alpen Diamonds60032181600321812026-09-04
07630243662753Alpen Diamonds60032183600321832026-09-04
07630243662777Alpen Diamonds60032185600321852026-09-04
07630243662791Alpen Diamonds60032187600321872026-09-04
07630243662814Alpen Diamonds60032189600321892026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397420390HIP Ultra Cleaning SolutionDent4You AGLDS2026-05-06
07640397422332HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422189HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
17640397422339HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
E308210050010Talos+ RIW-100TTW & H STERILIZATION SRLLDS2025-12-23
E308210060010Talos+ RIW-100UCW & H STERILIZATION SRLLDS2025-12-23
07640397421885HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421915HYDRIM L110W Instrument WasherDent4You AGLDS2025-01-15
07640397421922HYDRIM L110W Instrument WasherDent4You AGLDS2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07290110640606TIVA2 TDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640613TIVA2-H TDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640880TIVA10-1V-HS-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640897TIVA10-2V-HS-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110642013TIVA8-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
00852494007078CenorinCENORIN, L.L.C.LDS2021-07-15
00852494007085CenorinCENORIN, L.L.C.LDS2021-07-15
07540196001076HIPScican LtdLDS2020-11-09
07540196001083HIP UltraScican LtdLDS2020-11-09
07540196001090HIPScican LtdLDS2020-11-09
07540196000680HYDRIM L110W G4 Instrument WasherScican LtdLDS2018-09-07
07540196000994HYDRIM L110W G4 Instrument WasherScican LtdLDS2018-01-17
07540196001007HYDRIM L110W Instrument WasherScican LtdLDS2018-01-17