FDA.reportPublic FDA data

HLD Systems

Primary DI
00852494007009
Brand
HLD Systems
Company
CENORIN, L.L.C.
Model
610
Device description
Washer/Pasteurizer
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00852494007009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852494007009008524940070098524940070090852494007009

GMDN Terms#

Term, Definition table
TermDefinition
Pasteurization water bathA device usually in the form of a small heated water bath intended to be used to kill most infective agents on instruments by heating in water to 70? to 75? Celsius for a minimum of 20 minutes. This procedure is intended to provide disinfection for items where total sterility is not required.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
253-395-2400CustomerService@cenorin.com

Regulatory Flags#

DUNS number
157362497
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00852494007078Cenorin6102021-07-15
00852494007085Cenorin610HT2021-07-15

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
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