HYDRIM L110W Instrument Washer L110W-D01-L

GUDID 07640397421915

Automated instrument washer (Loaner)

Dent4You AG

Surgical instrument washer/disinfector (chemical/thermal)
Primary Device ID07640397421915
NIH Device Record Keya81133a3-0c46-44d4-94ad-2d5bcdb7b13c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYDRIM L110W Instrument Washer
Version Model NumberL110W-D01-L
Catalog NumberL110W-D01-L
Company DUNS480152811
Company NameDent4You AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196001007 [Previous]
GS107640397421915 [Primary]

FDA Product Code

LDSDevice, Pasteurization, Hot Water

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-23
Device Publish Date2025-01-15

On-Brand Devices [HYDRIM L110W Instrument Washer]

07640397421922Automated instrument washer (Refurbished)
07640397421915Automated instrument washer (Loaner)

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