Versajet 66800039

GUDID 00040565124759

Versajet II Hydrosurgery System Console

SMITH & NEPHEW MEDICAL LIMITED

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• Primary Device ID: 00040565124759
• NIH Device Record Key: 9ca5e57b-e0be-4d7f-8042-c372f7c0502d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versajet
• Version Model Number: 66800039
• Catalog Number: 66800039
• 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: false
• Serial Number: true
• 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	00040565124759 [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: 4
• Public Version Date: 2020-07-08
• Device Publish Date: 2016-09-20

On-Brand Devices [Versajet]

• 00040565125473: Versajet II Multifunction Footswitch
• 00040565124759: Versajet II Hydrosurgery System Console
• 00040565125497: Versajet II Console User Guide
• 30040565124781: Versajet II Hydrosurgery System Handset, 45deg 8mm PLUS
• 30040565124774: Versajet II Hydrosurgery System Handset, 45deg 14mm PLUS
• 30040565124767: Versajet II Hydrosurgery System Handset, 15deg 14mm PLUS
• 30040565124699: Versajet II Hydrosurgery System Handset, 45deg 8mm EXACT
• 30040565124682: Versajet II Hydrosurgery System Handset, 45deg 14mm EXACT
• 30040565124675: Versajet II Hydrosurgery System Handset, 15deg 14mm EXACT