GETINGE 9100-SERIES 9127E-001

GUDID 07340153710054

WASHER DISINFECTOR 9127E

Getinge Disinfection AB

Surgical utensil washer/disinfector
Primary Device ID07340153710054
NIH Device Record Keyde522513-4cb4-4778-99fe-0d754cc63b04
Commercial Distribution StatusIn Commercial Distribution
Brand NameGETINGE 9100-SERIES
Version Model Number9127E
Catalog Number9127E-001
Company DUNS354023236
Company NameGetinge Disinfection AB
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
GS107340153710054 [Primary]

FDA Product Code

MECDisinfector, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-16

On-Brand Devices [GETINGE 9100-SERIES]

07340153710078WASHER DISINFECTOR 9128EW
07340153710061WASHER DISINFECTOR 9128E
07340153710054WASHER DISINFECTOR 9127E
07340153710047WASHER DISINFECTOR 9125E
07340153710030WASHER DISINFECTOR 9122EW
07340153710023WASHER DISINFECTOR 9120E

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