Plastic BD Style Hub Tuohy Epidural Needle

GUDID M661S103418500

Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 5.00" Plastic Stylet, Marks, No Wing, Luer Connector

Spectra Medical Devices, LLC

Epidural needle, non-threaded

• Primary Device ID: M661S103418500
• NIH Device Record Key: 10187760-e6a6-4e2a-8f9e-b2f9ae6052f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plastic BD Style Hub Tuohy Epidural Needle
• Version Model Number: S10341-8.500LT
• 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	M661S103418500 [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 BD Style Hub Tuohy Epidural Needle ]

• M661S103418500: Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 5.00" Plastic Stylet, Marks, No Wing
• M661S103418350: Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Win
• M661S103417350: Plastic BD Style Hub Tuohy Epidural Needle, 17G Special x 3.50", Plastic Stylet, Marks, No Win