Versajet 66800041

GUDID 30040565124682

Versajet II Hydrosurgery System Handset, 45deg 14mm EXACT

SMITH & NEPHEW MEDICAL LIMITED

Water jet knife system handpiece, single-use

• Primary Device ID: 30040565124682
• NIH Device Record Key: 036e6d77-39f7-463b-8fe8-5a3e7141578a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versajet
• Version Model Number: 66800041
• Catalog Number: 66800041
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00040565124681 [Primary]
GS1	30040565124682 [Package]; Contains: 00040565124681; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143115

FDA Product Code

• FQH: Lavage, Jet

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• 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