Tuohy Epidural Needle

Primary DI
M661S885183501
Brand
Tuohy Epidural Needle
Company
Spectra Medical Devices, LLC
Model
S88518-3.501S
Device description
"Plastic Standard Hub Tuohy Epidural Needle,18G x 3.50"", Metal Stylet, Marks,Bevel Indicator"
Published
2024-02-12
Public version status
Update
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
M661S885183501PrimaryHIBCC0

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
M661S013182759Guidewire Introducer NeedleS013182759L2024-06-18
M661S010212753Guide Glide II® Guidewire Introducer NeedleS01021-2.753L2024-02-12
M661S01318275Guide Glide II® Guidewire Introducer NeedleS01318-2.759LF2023-10-13
M661S01321275Guide Glide II® Guidewire Introducer NeedleS01321-2.759LF2023-10-12
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
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

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Primary DI, Brand, Company table
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