STATIM 5000 G4 Cassette Autoclave G4-211103

GUDID 07640397421663

Table-top steam sterilizer with removable extended cassette sterilization chamber

Dent4You AG

Steam sterilizer
Primary Device ID07640397421663
NIH Device Record Keycd4fc74a-2f5d-4a42-9615-f9e77571a12d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTATIM 5000 G4 Cassette Autoclave
Version Model NumberG4-211103
Catalog NumberG4-211103
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
GS107540196003179 [Previous]
GS107640397421663 [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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