VERSAJET™ II 66800475

GUDID 00040565125503

Versajet II Replacement shelf

SMITH & NEPHEW MEDICAL LIMITED

Electromechanical device/system transport trolley

• Primary Device ID: 00040565125503
• NIH Device Record Key: 27d9abd1-0779-4d11-a7e2-064baebee9a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSAJET™ II
• Version Model Number: 66800475
• Catalog Number: 66800475
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565125503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143115

FDA Product Code

• FQH: Lavage, Jet

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-22
• Device Publish Date: 2018-08-31

On-Brand Devices [VERSAJET™ II]

• 00040565125503: Versajet II Replacement shelf
• 00040565125978: Versajet II Surgical Cart