FDA.reportPublic FDA data

Easydrip ReadyGard Duo Safety Pen Needles 30G×5mm

Primary DI
16972857293571
Brand
Easydrip ReadyGard Duo Safety Pen Needles 30G×5mm
Company
Sandstone Medical (Suzhou) Inc.
Model
HS 05-3005
Published
2024-10-11
Public version status
New
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
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
36972857293575PackageGS1800In Commercial Distribution
16972857293571PrimaryGS10
06972857293574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697285729357536972857293575
1697285729357116972857293571
06972857293574069728572935746972857293574

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.

Regulatory Flags#

DUNS number
554500882
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
16972857295148Easydrip SafeGard Duo Safety Pen NeedlesHS2025-07-08
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
36972857294749Easydrip Plus Pen Needles02-32062025-05-17
16972857294325Easydrip Pen Needles01-32042025-02-28
36972857294329Easydrip Pen Needles01-32042025-02-28
16972857293854Easydrip Plus Pen Needles 32G×4mm02-32042024-11-11
36972857293858Easydrip Plus Pen Needles 32G×4mm02-32042024-11-11
16972857293847SOL-M Pen Needles 32G×4mm02-32042024-11-05
36972857293841SOL-M Pen Needles 32G×4mm02-32042024-11-05
16972857291911easydrip Cassic Pen Needles01-31052023-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27