FDA.reportPublic FDA data

Future Generation Medical

Primary DI
00850046230172
Brand
Future Generation Medical
Company
Global International L. L. C.
Model
AL25SQ
Device description
FGM Spinal Needle 25G Quincke Tip
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K171518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171518000Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd.2018-01-05BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046230179PrimaryGS10
00850046230172Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004623017910850046230179
00850046230172008500462301728500462301720850046230172

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

Contacts#

Phone, Email table
PhoneEmail
(888) 291-7638info@fgmmedical.com

Regulatory Flags#

DUNS number
079251688
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850046230032Future Generation Medical FGMHOT04052022-11-13
10850046230049Future Generation Medical FGMHOT0425 2022-11-13
10850046230094Future Generation Medical FG-IHW-50032022-11-13
10850046230100Future Generation Medical FG-IHW-5003A2022-11-13
10850046230247Future Generation Medical FGTS-85912022-11-13
10850046230254Future Generation Medical FGTS-8591A2022-11-13
10850046230261Future Generation Medical FGGTS-65912022-11-13
10850046230278Future Generation Medical FG-HCP09162022-11-13
10850046230315Future Generation Medical FGM-D07262022-11-21
10850046230322Future Generation Medical FGM-D03152022-11-21
10850046230339Future Generation Medical FGM-D08242022-11-21
20850046230305Future Generation Medical FGM-D18472022-11-21
10850046230148Future Generation Medical AL29SQ2022-12-05
10850046230155Future Generation Medical AL27SQ2022-12-05
10850046230162Future Generation Medical AL26SQ2022-12-05
10850046230179Future Generation Medical AL25SQ2022-12-05
10850046230186Future Generation Medical AL22SQ2022-12-05
10850046230193Future Generation Medical AL20SQ2022-12-05
10850046230209Future Generation Medical AL19SQ2022-12-05
10850046230216Future Generation Medical AL18SQ2022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
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
05060498301626Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301657Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301770Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306898Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306928Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498307345Dash 6 NRFit™GBUK GROUP LIMITEDBSP2023-06-02
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