HydroCision Console 52700

GUDID 00853235007043

HydroCision Console

HYDROCISION, INC.

Water jet knife system generator

• Primary Device ID: 00853235007043
• NIH Device Record Key: cb1e2f16-ccbf-45a2-98eb-79c3384fe0cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroCision Console
• Version Model Number: 52700
• Catalog Number: 52700
• Company DUNS: 834612764
• Company Name: HYDROCISION, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853235007043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002764

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-23

On-Brand Devices [HydroCision Console]

• 00853235007043: HydroCision Console
• 00853235007333: HydroSurgical Console