VERSAJET III PRECISION Hydrosurgery System Hand Piece 66802147

GUDID 05000223498122

VERSAJET III PRECISION HANDPIECE 15DEGx14MM

SMITH & NEPHEW MEDICAL LIMITED

Water jet knife system handpiece, single-use

• Primary Device ID: 05000223498122
• NIH Device Record Key: aaa02d64-fd70-433c-b586-d52222999212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSAJET III PRECISION Hydrosurgery System Hand Piece
• Version Model Number: 66802147
• Catalog Number: 66802147
• 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: 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 Dimensions

• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0
• Angle: 15 degree
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223498115 [Primary]
GS1	05000223498122 [Package]; Contains: 05000223498115; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220964

FDA Product Code

• FQH: Lavage, Jet

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [VERSAJET III PRECISION Hydrosurgery System Hand Piece]

• 05000223498160: VERSAJET III PRECISION HANDPIECE 45DEGx8MM
• 05000223498146: VERSAJET III PRECISION HANDPIECE 45DEGx14MM
• 05000223498122: VERSAJET III PRECISION HANDPIECE 15DEGx14MM