Lexa PLUS RIS-311 19933100

GUDID E30819933100

TABLE-TOP STEAM STERILIZER LEXA PLUS RIS-311

W & H STERILIZATION SRL

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