Plastic Standard Hub Tuohy Epidural Needle

GUDID M661S075185001

Plastic Standard Hub Tuohy Epidural Needle, 18G x 5.00", Metal Stylet, No Wing

Spectra Medical Devices, LLC

Epidural needle, non-threaded

• Primary Device ID: M661S075185001
• NIH Device Record Key: 2d094042-e31e-4643-880c-2020e75f0629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plastic Standard Hub Tuohy Epidural Needle
• Version Model Number: S07518-5.001B
• 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	M661S075185001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854816

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: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [Plastic Standard Hub Tuohy Epidural Needle]

• M661S075185001: Plastic Standard Hub Tuohy Epidural Needle, 18G x 5.00", Metal Stylet, No Wing
• M661S075183501: Plastic Standard Hub Tuohy Epidural Needle, 18G x 3.50" Metal Stylet, No Wing
• M661S075175001: Plastic Standard Hub Tuohy Epidural Needle, 17G x 5.00" Metal Stylet, No Wing
• M661S075173501: Plastic Standard Hub Tuohy Epidural Needle, 17G x 3.50", Metal Stylet, No Wing