Getinge GSS610N Series Steam Sterilizer

GUDID 04053275000219

MAQUET GmbH

Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer

• Primary Device ID: 04053275000219
• NIH Device Record Key: 5de63213-1660-4027-a105-9db5003b0897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge GSS610N Series Steam Sterilizer
• Version Model Number: 610N21
• Company DUNS: 315435859
• Company Name: MAQUET GmbH
• 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	04053275000219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214120

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: 2023-03-10
• Device Publish Date: 2023-03-02

On-Brand Devices [Getinge GSS610N Series Steam Sterilizer]

• 04053275000080: 610N15
• 04053275000073: 610N14
• 04053275000066: 610N10
• 04053275000219: 610N21