Plastic BD Style Hub Tuohy Epidural Needle

Primary DI
M661S103418350
Brand
Plastic BD Style Hub Tuohy Epidural Needle
Company
Spectra Medical Devices, LLC
Model
S103418-3.50LT
Device description
Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Wing, Luer Connector
Published
2024-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854816000EPIDURAL ANESTHESIA NEEDLESReganes, Inc.1985-12-19BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M661S103418350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

Regulatory Flags#

DUNS number
118301171
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleS103417-3.50NL2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleS10341-8.500LT2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleS80C21-6.00BLX2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleS80C22-2.00BLX2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleS80C23-2.00BL2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleS90C22-6.00BLX2024-06-18
M661S80C21200MSK Ultrasonic Injection NeedleS80C21-2.00BLX2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleS80C21-4.00BLX2024-02-12
M661SST221505Radiofrequency (RF) NeedleSST221505SL2024-06-18
M661S013182759Guidewire Introducer NeedleS013182759L2024-06-18
M661S075173501Plastic Standard Hub Tuohy Epidural NeedleS07517-3.501B2024-06-18
M661S075175001Plastic Standard Hub Tuohy Epidural NeedleS07517-5.001B2024-06-18
M661S075183501Plastic Standard Hub Tuohy Epidural NeedleS07518-3.501B2024-06-18
M661S075185001Plastic Standard Hub Tuohy Epidural NeedleS07518-5.001B2024-06-18
M661S135143508Metal Standard Hub Tuohy Epidural NeedleS13514-3.508C2024-06-18
M661S135144008Metal Standard Hub Tuohy Epidural NeedleS13514-4.008C2024-06-18
M661S135173008Metal Standard Hub Tuohy Epidural NeedleS13517-3.008B2024-06-18
M661S135173508Metal Standard Hub Tuohy Epidural NeedleS13517-3.508A2024-06-18
M661S135173828Metal Standard Hub Tuohy Epidural NeedleS13517-3.828A2024-06-18
M661S135175008Metal Standard Hub Tuohy Epidural NeedleS13517-5.008A2024-06-18

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