Radiofrequency (RF) Needle

GUDID M661SCV201010

20G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Cap

Spectra Medical Devices, LLC

Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use

• Primary Device ID: M661SCV201010
• NIH Device Record Key: cfa6ba40-2fb8-4a43-8d5e-fb4a4d969f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiofrequency (RF) Needle
• Version Model Number: SCV201010NC
• 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	M661SCV201010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032196

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

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 [Radiofrequency (RF) Needle]

• M661SCV201010: 20G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow
• M661SCV200510: 20G x 5cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Yellow Cap
• M661SCV200505: 20G x 5cm x 5mm Active Tip, Sharp RF Needle, No Echogenic Tip & Lubrication, Curved, Yellow Cap
• M661SCV181510: 18G x 15cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Pink Cap
• M661SCV181010: 18G x 10cm x 10mm Active Tip, Sharp RF Needle, No Echogenic Tip, Lubricated, Curved, Pink Cap