FDA.reportPublic FDA data

Easydrip ReadyGard Safety Pen Needles 30G×8mm

Primary DI
36972857293612
Brand
Easydrip ReadyGard Safety Pen Needles 30G×8mm
Company
Sandstone Medical (Suzhou) Inc.
Model
HE 06-3008
Published
2024-10-16
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

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210864000Safety Pen NeedleSandstone Medical (Suzhou), Inc.2022-02-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36972857293612PackageGS1800In Commercial Distribution
16972857293618PrimaryGS10
06972857293611Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697285729361236972857293612
1697285729361816972857293618
06972857293611069728572936116972857293611

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554500882
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972857299252Pen Needles04-31052026-09-24
06972857295677contour comfort Pen Needle04-32042026-08-19
16972857297784Easydrip Glider5 Classic Pro Pen Needles03-31052026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen Needles04-32042026-07-09
16972857295148Easydrip SafeGard Duo Safety Pen Needles05-30052025-07-08
16972857299290Easydrip Readygard Duo05-30052026-10-09
16972857299306Easydrip Readygard06-30052026-10-09
16972857299313Easydrip Readygard06-30082026-10-09
16972857299337Pen Needles Classic01-32042026-10-11
16972857296350MireMed PEN TIPS02-32042026-04-30
16972857296008Easydrip Pen Needles01-31082025-12-12
36972857296002Easydrip Pen Needles01-31082025-12-12
16972857295186Rapha Pen Needles01-32042025-07-31
16972857295193EveryMeds Pen Needles01-32042025-07-31
36972857295180Rapha Pen Needles01-32042025-07-31
36972857295197EveryMeds Pen Needles01-32042025-07-31
36972857295142Easydrip SafeGard Duo Safety Pen NeedlesHS2025-07-08
16972857294738Easydrip Plus Pen Needles02-31082025-05-17
16972857294745Easydrip Plus Pen Needles02-32062025-05-17
36972857294732Easydrip Plus Pen Needles02-31082025-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone 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
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11