Metal Standard Hub Tuohy Epidural Needle

GUDID M661S135173828

Metal Standard Hub Tuohy Epidural Needle, 17G x 3.82", Marks

Spectra Medical Devices, LLC

Epidural needle, non-threaded

• Primary Device ID: M661S135173828
• NIH Device Record Key: ac0177d0-ac45-4f1a-9df1-d8d84ba27d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metal Standard Hub Tuohy Epidural Needle
• Version Model Number: S13517-3.828A
• 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	M661S135173828 [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 [Metal Standard Hub Tuohy Epidural Needle]

• M661S135183508: Metal Standard Hub Tuohy Epidural Needle, 18G x 3.50", Marks
• M661S135176008: Metal Standard Hub Tuohy Epidural Needle, 17G x 6.00", Marks
• M661S135175008: Metal Standard Hub Tuohy Epidural Needle, 17G x 5.00", Marks
• M661S135173828: Metal Standard Hub Tuohy Epidural Needle, 17G x 3.82", Marks
• M661S135173508: Metal Standard Hub Tuohy Epidural Needle, 17G x 3.50", Marks
• M661S135173008: Metal Standard Hub Tuohy Epidural Needle, 17G x 3.00", Marks
• M661S135144008: Metal Standard Hub Tuohy Epidural Needle, 14G x 4.00", Marks
• M661S135143508: Metal Standard Hub Tuohy Epidural Needle, 14G x 3.50", Marks