FDA.reportPublic FDA data

Future Generation Medical

Primary DI
10850046230209
Brand
Future Generation Medical
Company
Global International L. L. C.
Model
AL19SQ
Device description
FGM Spinal Needle 19G Quincke Tip
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10850046230209PrimaryGS10
00850046230202Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004623020910850046230209
00850046230202008500462302028500462302020850046230202

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. 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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
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
10850046230216Future Generation Medical AL18SQ2022-12-05
00850046230141Future Generation Medical AL29SQ2022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
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
10680651478181HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478785HalyardAvanos Medical, Inc.BSP2019-06-15
10680651476439HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477061HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477474HalyardAvanos Medical, Inc.BSP2019-02-21
10680651476422HalyardAvanos Medical, Inc.BSP2019-01-23
10680651476118HalyardAvanos Medical, Inc.BSP2019-01-11
10680651475630HalyardAvanos Medical, Inc.BSP2018-11-13
10680651475142HalyardAvanos Medical, Inc.BSP2018-09-23
10680651475036HalyardAvanos Medical, Inc.BSP2018-07-25
10680651474978HalyardAvanos Medical, Inc.BSP2018-07-13
10680651474688HalyardAvanos Medical, Inc.BSP2018-06-22
10680651474275HalyardAvanos Medical, Inc.BSP2018-05-10