Lexa PLUS RIS-311 19933100

GUDID E30819933100

TABLE-TOP STEAM STERILIZER LEXA PLUS RIS-311

W & H STERILIZATION SRL

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: E30819933100
• NIH Device Record Key: 43398697-aa70-4eec-a613-274ff5fc432b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lexa PLUS RIS-311
• Version Model Number: Lexa PLUS RIS-311
• Catalog Number: 19933100
• Company DUNS: 429111904
• Company Name: W & H STERILIZATION SRL
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E30819933100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213758

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [Lexa PLUS RIS-311]

• E30819933101: TABLE-TOP STEAM STERILIZER LEXA PLUS RIS-311
• E30819933100: TABLE-TOP STEAM STERILIZER LEXA PLUS RIS-311