FDA.reportPublic FDA data

GERTIE MARX SPINAL N

Primary DI
B27422150I0
Brand
GERTIE MARX SPINAL N
Company
International Medical Development Corporation
Model
GM22150-I
Device description
SPINAL NEEDLE
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K170112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170112000IMD's Lumbar Puncture NeedleInternational Medical Development, Inc.(Imd)2018-02-02BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B27422150I0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to deliver anaesthetic or analgesic agents intrathecally (in the space under the arachnoid membrane of the brain and spinal cord), withdraw a sample of cerebrospinal fluid (CSF), and/or assist introduction of an intrathecal catheter (e.g., lumboperitoneal shunt, spinal catheter). It is typically fenestrated, spring-tipped, and used for short-term administration; it is typically made of metal and plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
078483253
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B27422124I0GERTIE MARX SPINAL NGM22124-I2023-09-01
B27422190I0GERTIE MARX SPINAL NGM22190-I2023-09-01
B2742270I0GERTIE MARX SPINAL NGM2270-I2023-09-01
B2742290I0GERTIE MARX SPINAL NGM2290-I2023-09-01
B27424101I0GERTIE MARX SPINAL NGM24101-I2023-09-01
B27424124I0GERTIE MARX SPINAL NGM24124-I2023-09-01
B27424150I0GERTIE MARX SPINAL NGM2550-I2023-09-01
B2742450I0GERTIE MARX SPINAL NGM2450-I2023-09-01
B2742490I0GERTIE MARX SPINAL NGM2490-I2023-09-01
B27425101I0GERTIE MARX SPINAL NGM25101-I2023-09-01
B27425124I0GERTIE MARX SPINAL NGM25124-I2023-09-01
B27425160I0GERTIE MARX SPINAL NGM25160-I2023-09-01
B2742550I0GERTIE MARX SPINAL NGM2550-I2023-09-01
B2742590I0GERTIE MARX SPINAL NGM2590-I2023-09-01
B274EP17350GERTIE MARX SPINAL NEP17352023-09-01
B274EP1750GERTIE MARX SPINAL NEP1752023-09-01
B274EP1760GERTIE MARX SPINAL NEP1762023-09-01
B274EP1770GERTIE MARX SPINAL NEP1772023-09-01
B274FNB2090I80GERTIE MARX SPINAL NFNB2090-I-82023-09-01
B274GM2190I0GERTIE MARX SPINAL NGM25190-I2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
00382904003715BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003722BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003739BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15