FDA.reportPublic FDA data

Metal Standard Hub Tuohy Epidural Needle

Primary DI
M661S135183508
Brand
Metal Standard Hub Tuohy Epidural Needle
Company
Spectra Medical Devices, LLC
Model
S13518-3.508B
Device description
"Metal Standard Hub Tuohy Epidural Needle, 18G x 3.50"", Marks"
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
M661S135183508PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118301171
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleS103417-3.50NL2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleS103418-3.50LT2024-06-18
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

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