Guidewire Introducer Needle

GUDID M661S013182759

18G x 2.75" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator

Spectra Medical Devices, LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: M661S013182759
• NIH Device Record Key: e66f4f46-a83e-4cff-9fa2-2364c5cc9d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidewire Introducer Needle
• Version Model Number: S013182759L
• 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	M661S013182759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082580

FDA Product Code

• DYB: Introducer, Catheter

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

Devices Manufactured by Spectra Medical Devices, LLC

• M661S013182759 - Guidewire Introducer Needle: 2024-06-2618G x 2.75" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator
• M661S013182759 - Guidewire Introducer Needle: 2024-06-26 18G x 2.75" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator
• M661S075173501 - Plastic Standard Hub Tuohy Epidural Needle: 2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 17G x 3.50", Metal Stylet, No Wing
• M661S075175001 - Plastic Standard Hub Tuohy Epidural Needle: 2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 17G x 5.00" Metal Stylet, No Wing
• M661S075183501 - Plastic Standard Hub Tuohy Epidural Needle: 2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 18G x 3.50" Metal Stylet, No Wing
• M661S075185001 - Plastic Standard Hub Tuohy Epidural Needle: 2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 18G x 5.00", Metal Stylet, No Wing
• M661S103417350 - Plastic BD Style Hub Tuohy Epidural Needle: 2024-06-26 Plastic BD Style Hub Tuohy Epidural Needle, 17G Special x 3.50", Plastic Stylet, Marks, No Wing, NRFit Connector
• M661S103418350 - Plastic BD Style Hub Tuohy Epidural Needle: 2024-06-26 Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Wing, Luer Connector
• M661S103418500 - Plastic BD Style Hub Tuohy Epidural Needle: 2024-06-26 Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 5.00" Plastic Stylet, Marks, No Wing, Luer Connector