Getinge GSS610N Series Steam Sterilizer

GUDID 04053275000066

MAQUET GmbH

Steam sterilizer

• Primary Device ID: 04053275000066
• NIH Device Record Key: 8afa9b7f-7f47-4ef3-a9ee-e55dcf9277ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge GSS610N Series Steam Sterilizer
• Version Model Number: 610N10
• 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	04053275000066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201927

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: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [Getinge GSS610N Series Steam Sterilizer]

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