SpineJet® PerResector-China Version 56000

GUDID 00853235007326

SpineJet® Percutaneous Hydrodiscectomy Set

HYDROCISION, INC.

Water jet knife system handpiece, single-use

• Primary Device ID: 00853235007326
• NIH Device Record Key: e5b2a73d-d1f1-4ae9-bfc0-9236343bc588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineJet® PerResector-China Version
• Version Model Number: 56000
• Catalog Number: 56000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00853235007326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002764

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-21

Devices Manufactured by HYDROCISION, INC.

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• 00853235007005 - TenJet®: 2018-07-06 TenJet® Percutaneous Hydrotenotomy Set
• 00853235007012 - TenJet®: 2018-07-06 TenJet® Accessory Set
• 00853235007029 - TenJet®: 2018-07-06 TenJet® Percutaneous Hydrotenotomy Set
• 00853235007036 - SpineJet®: 2018-07-06 SpineJet® MicroResector
• 00853235007043 - HydroCision Console: 2018-07-06 HydroCision Console
• 00853235007050 - SpineJet®: 2018-07-06 SpineJet® Quick Connector
• 00853235007067 - SpineJet®: 2018-07-06 SpineJet® Percutaneous Hydrodiscectomy Set with Access Set