SpineWand

GUDID 05060696460026

Perc DC Convenience Pack Inc 19 gauge 3” Needle

MORGAN STEER ORTHOPAEDICS LIMITED

Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 05060696460026
• NIH Device Record Key: e4ea57fc-1171-43c7-9760-6c8f28fbcb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineWand
• Version Model Number: SDC01-01
• Company DUNS: 216776681
• Company Name: MORGAN STEER ORTHOPAEDICS 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060696460026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061259

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2024-06-11
• Device Publish Date: 2024-06-03

On-Brand Devices [SpineWand]

• 05060696460057: CIQ Perc DLR Spinewand for Coblator IQ Controller
• 05060696460040: CIQ Perc DLG Spinewand for Coblator IQ Controller
• 05060696460033: CIQ Perc DC Spinewand for Coblator IQ Controller
• 05060696460026: Perc DC Convenience Pack Inc 19 gauge 3” Needle
• 05060696460019: Perc DLG Convenience Pack inc 17 gauge 8” Crawford Needle
• 05060696460002: Perc DLR Convenience Pack Inc 17 gauge 6” Crawford Needle