HydroCision Console 82700

GUDID 00853235007333

HydroSurgical Console

HYDROCISION, INC.

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• Primary Device ID: 00853235007333
• NIH Device Record Key: 81043732-4fc8-482a-93fe-f4c73fd32ea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroCision Console
• Version Model Number: 82700
• Catalog Number: 82700
• 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	00853235007333 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [HydroCision Console]

• 00853235007043: HydroCision Console
• 00853235007333: HydroSurgical Console