SpineJet® 56971

GUDID 00853235007081

SpineJet® Microdisectomy Access Set

HYDROCISION, INC.

Water jet knife system handpiece, single-use

• Primary Device ID: 00853235007081
• NIH Device Record Key: 6a1b73ab-e217-48f3-bb6c-4b4ea06c8c72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineJet®
• Version Model Number: 56971
• Catalog Number: 56971
• 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: true
• 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	00853235007081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002764

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

On-Brand Devices [SpineJet®]

• 00853235007289: SpineJet® Microdiscectomy Access Set, 4.0 Cannula
• 00853235007272: SpineJet® Access Set, Instrument Tray
• 00853235007258: SpineJet® 4.0 Percutaneous Access Set, 7.5" Dilator
• 00853235007241: SpineJet® Access Set, 8" Needle
• 00853235007210: SpineJet® +10° DL Push
• 00853235007203: SpineJet® -10° DL Pull
• 00853235007197: SpineJet® 20° XLE
• 00853235007180: SpineJet® 30°XL MIS-Rectangle
• 00853235007173: SpineJet® 20° XL MIS-Rectangle
• 00853235007166: SpineJet® 30° XL MIS OVAL
• 00853235007159: SpineJet® 20° XL MIS-Oval
• 00853235007142: SpineJet® 75° XLS-Rectangle
• 00853235007135: SpineJet® 20 XLS Rectangle
• 00853235007128: SpineJet® 75° XLS-OVAL
• 00853235007111: SpineJet® 20° XLS-OVAL
• 00853235007104: SpineJet® Percutaneous Access Curved Set-Disposable
• 00853235007098: SpineJet® Percutaneous Access straight Set-Diposable
• 00853235007081: SpineJet® Microdisectomy Access Set
• 00853235007074: SpineJet® EndoResector
• 00853235007067: SpineJet® Percutaneous Hydrodiscectomy Set with Access Set
• 00853235007050: SpineJet® Quick Connector
• 00853235007036: SpineJet® MicroResector