MSK Ultrasonic Injection Needle

GUDID M661S80C21400

21G TW x 4.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lubricated, Extruded Protector with Extension Set

Spectra Medical Devices, LLC

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• Primary Device ID: M661S80C21400
• NIH Device Record Key: e6fb8577-7ce9-4c3b-bce4-89939055aa0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSK Ultrasonic Injection Needle
• Version Model Number: S80C21-4.00BLX
• Company DUNS: 118301171
• Company Name: Spectra Medical Devices, LLC
• 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: false
• 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
HIBCC	M661S80C21400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151069

FDA Product Code

• BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

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: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [MSK Ultrasonic Injection Needle]

• M661S80C21400: 21G TW x 4.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lub
• M661S80C21200: 21G TW x 2.00" MSK Ultrasonic Injection Needle, C-Bevel, Echo Dimpling, No Marks, Green Hub, Lub