FDA.reportPublic FDA data

HIP Ultra

Primary DI
07540196001083
Brand
HIP Ultra
Company
Scican Ltd
Model
CS-HIPC-U
Catalog number
CS-HIPC-U
Device description
HIP Ultra Cleaning Solution with Instrument Protection. For the Hydrim C61.
Published
2020-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
17540196001080PackageGS18In Commercial Distribution
07540196001083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019600108017540196001080
07540196001083075401960010837540196001083

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.

Contacts#

Phone, Email table
PhoneEmail
18006677733tboyce@scican.com

Regulatory Flags#

DUNS number
204137145
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
07540196001786STATCLAVE G4 Chamber AutoclaveG4-621103G4-6211032019-08-13
07540196003803STATCLAVE G4 Chamber AutoclaveG4-621103-RG4-621103-R2022-04-07
07540196003810STATCLAVE G4 Chamber AutoclaveG4-621103-LG4-621103-L2022-04-07
07540196001793STATCLAVE G4 Chamber AutoclaveG4-622303G4-6223032021-08-18
07540196003179STATIM 5000 G4 Cassette AutoclaveG4-211103G4-2111032023-06-26
07540196003186STATIM 5000 G4 Cassette AutoclaveG4-211103-LG4-211103-L2023-06-26
07540196003193STATIM 5000 G4 Cassette AutoclaveG4-211103-RG4-211103-R2023-06-26
07540196002455BRAVO G4 Chamber Autoclave7A6200307A6200302022-11-18
07540196002462BRAVO G4 Chamber Autoclave7A6210307A6210302022-11-18
07540196002479BRAVO G4 Chamber Autoclave7A6200107A6200102022-11-18
07540196002486BRAVO G4 Chamber Autoclave7A6210107A6210102022-11-18
07540196000420STATIM 5000 G4 Cassette AutoclaveG4-201103G4-2011032016-08-02
07540196000437STATIM 5000 G4 Cassette AutoclaveG4-201103-LG4-201103-L2016-08-02
07540196000444STATIM 5000 G4 Cassette AutoclaveG4-201103-RG4-201103-R2016-08-02
07540196000451STATIM 2000 G4 Cassette AutoclaveG4-121101G4-1211012016-08-02
07540196000475STATIM 2000 G4 Cassette AutoclaveG4-121101-RG4-121101-R2016-08-02
07540196000642HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012016-08-02
07540196000666HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01C61WD-D012016-08-02
07540196000673HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01-LCS C61WD-D01-LCS 2016-08-02
07540196001250HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2018-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397420390HIP Ultra Cleaning SolutionDent4You AGLDS2026-05-06
07640397420406HIP 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
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