STATCLAVE G4 Chamber Autoclave G4-621103-R

GUDID 07640397421748

Dynamic-air-removal (pre-vacuum) table-top steam sterilizer (Refurbished)

Dent4You AG

Steam sterilizer

• Primary Device ID: 07640397421748
• NIH Device Record Key: 136f3343-b42b-412e-9a5a-69ed587957f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATCLAVE G4 Chamber Autoclave
• Version Model Number: G4-621103-R
• Catalog Number: G4-621103-R
• 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	07540196003803 [Previous]
GS1	07640397421748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190062

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: 2026-01-14
• Device Publish Date: 2026-01-06

On-Brand Devices [STATCLAVE G4 Chamber Autoclave]

• 07640397421793: Dynamic-air-removal (pre-vacuum) table-top steam sterilizer, 208-240V
• 07640397421755: Dynamic-air-removal (pre-vacuum) table-top steam sterilizer (Loaner)
• 07640397421748: Dynamic-air-removal (pre-vacuum) table-top steam sterilizer (Refurbished)
• 07640397421731: Dynamic-air-removal (pre-vacuum) table-top steam sterilizer