STATIM 5000 G4 Cassette Autoclave G4-201103-L

GUDID 07640397421595

Table-top steam sterilizer with removable cassette sterilization chamber (Loaner)

Dent4You AG

Steam sterilizer
Primary Device ID07640397421595
NIH Device Record Key0014d2bb-1821-4d3d-9713-4b8bd45c804e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTATIM 5000 G4 Cassette Autoclave
Version Model NumberG4-201103-L
Catalog NumberG4-201103-L
Company DUNS480152811
Company NameDent4You AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS107540196000437 [Previous]
GS107640397421595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-30
Device Publish Date2025-07-22

On-Brand Devices [STATIM 5000 G4 Cassette Autoclave]

07640397421687Table-top steam sterilizer with removable extended cassette sterilization chamber (Refurbished)
07640397421670Table-top steam sterilizer with removable extended cassette sterilization chamber (Loaner)
07640397421663Table-top steam sterilizer with removable extended cassette sterilization chamber
07640397421601Table-top steam sterilizer with removable cassette sterilization chamber (Refurbished)
07640397421595Table-top steam sterilizer with removable cassette sterilization chamber (Loaner)
07640397421588Table-top steam sterilizer with removable cassette sterilization chamber

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