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 IDM661S013182759
NIH Device Record Keye66f4f46-a83e-4cff-9fa2-2364c5cc9d7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuidewire Introducer Needle
Version Model NumberS013182759L
Company DUNS118301171
Company NameSpectra Medical Devices, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM661S013182759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-26
Device Publish Date2024-06-18

Devices Manufactured by Spectra Medical Devices, LLC

M661S013182759 - Guidewire Introducer Needle2024-06-2618G x 2.75" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator
M661S013182759 - Guidewire Introducer Needle2024-06-26 18G x 2.75" GWI, Pink Hub, B-Bevel, Echo Tip, Lubricated, Bevel Indicator
M661S075173501 - Plastic Standard Hub Tuohy Epidural Needle2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 17G x 3.50", Metal Stylet, No Wing
M661S075175001 - Plastic Standard Hub Tuohy Epidural Needle2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 17G x 5.00" Metal Stylet, No Wing
M661S075183501 - Plastic Standard Hub Tuohy Epidural Needle2024-06-26 Plastic Standard Hub Tuohy Epidural Needle, 18G x 3.50" Metal Stylet, No Wing
M661S075185001 - Plastic Standard Hub Tuohy Epidural Needle2024-06-26 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.