STATIM 2000 G4 Cassette Autoclave G4-121101-L

GUDID 07640397421427

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

Dent4You AG

Steam sterilizer

• Primary Device ID: 07640397421427
• NIH Device Record Key: 76ca2c31-a3fb-4252-addd-1c36dee964d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATIM 2000 G4 Cassette Autoclave
• Version Model Number: G4-121101-L
• Catalog Number: G4-121101-L
• Company DUNS: 480152811
• Company Name: Dent4You AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540196000468 [Previous]
GS1	07640397421427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112872

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-30
• Device Publish Date: 2025-07-22

On-Brand Devices [STATIM 2000 G4 Cassette Autoclave]

• 07640397421434: Table-top steam sterilizer with removable cassette sterilization chamber (Refurbished)
• 07640397421427: Table-top steam sterilizer with removable cassette sterilization chamber (Loaner)
• 07640397421410: Table-top steam sterilizer with removable cassette sterilization chamber