FDA.reportPublic FDA data

NEEDLES 23x1

Primary DI
00369771001815
Brand
NEEDLES 23x1
Company
GERI-GENTLE CORPORATION
Model
11-231
Device description
NEEDLES 23x1
Published
2021-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00369771001822PackageGS1100In Commercial Distribution
00369771001815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00369771001822003697710018223697710018220369771001822
00369771001815003697710018153697710018150369771001815

GMDN Terms#

Term, Definition table
TermDefinition
Medication cartridge syringe, safety-needleA sterile device consisting of a breech-loading metal barrel with plunger into which a hermetically-sealed glass cartridge containing medication is intended to fit. The device uses an attached protective recessed or shielded needle for hypodermic drug delivery. This is a single-use device.

Regulatory Flags#

DUNS number
361663839
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00369771003390Pen Needle11-3052023-09-01
10369771000891Syringes Safety114662019-06-01
10369771000907Syringes Safety114672019-06-01
00369771000832Syringes Safety114662022-05-01
00369771001846NEEDLES 25x111-2512021-01-01
00369771001877NEEDLES 25x5/811-25582021-01-01
00369771001785Syringe 3ml11-3002021-01-01
00369771001525HMEF w/ Flextube19-HMEF1002020-06-01
00369771003642Sharps Collector 5QT111382023-11-01
00369771003659Sharps Collector 5QT111382023-11-01
00369771003420Prefilled Syrings11-10102023-09-01
00369771003437Prefilled Syrings11-10102023-09-01
10369771000785Lancets Safety25-4572023-08-01
00369771003161Oxygen Concentrator19-50002023-08-01
20369771000782Lancets Safety25-4572023-08-01
00369771001273Gloves120972019-09-01
00369771001365Gloves122902019-09-01
00369771001389Gloves122912019-09-01
00369771001402Gloves12-3092019-09-01
00369771001426Gloves128902019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850068519361SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519378SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26