VERSAJET™ II 66800979

GUDID 00040565125978

Versajet II Surgical Cart

SMITH & NEPHEW MEDICAL LIMITED

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• Primary Device ID: 00040565125978
• NIH Device Record Key: fe2813d6-f8a0-4d3e-b3a2-b2783b03d27d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSAJET™ II
• Version Model Number: 66800979
• Catalog Number: 66800979
• 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	00040565125978 [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: 2023-09-07
• Device Publish Date: 2018-08-31

On-Brand Devices [VERSAJET™ II]

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