FDA.reportPublic FDA data

STERiJECT TM

Primary DI
04580708067445
Brand
STERiJECT TM
Company
TSK LABORATORY, JAPAN
Model
LDS-27006I
Device description
TSK STERiJECT Premium Disposable Hypodermic Needle
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K970370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970370000TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLETsk Laboratory, Japan1997-04-10FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14580708067442PackageGS160In Commercial Distribution
04580708067445PrimaryGS10
04580708067438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458070806744214580708067442
04580708067445045807080674454580708067445
04580708067438045807080674384580708067438

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter
Outer Diameter0.4Millimeter

Regulatory Flags#

DUNS number
690646096
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
04580708068527STERiJECT TMPRE-25013I2026-01-15
04580708068534STERiJECT TMPRE-25013I2026-01-15
14580708068524STERiJECT TMPRE-25013I2026-01-15
24580708068538STERiJECT TMPRE-25013I2026-01-15
14580708067442STERiJECT TMLDS-27006I2025-08-18
04571225317625STERiJECT TMHPC-31013E2024-06-11
14571225317622STERiJECT TMHPC-31013E2024-06-11
14571225314157STERiJECT TMHPC-27013I2024-06-10
14571225314218STERiJECT TMHPC-30013I2024-06-10
04571225314105STERiJECT TMHPC-23013I2024-06-10
04571225314112STERiJECT TMHPC-23013I2024-06-10
04571225314198STERiJECT TMHPC-27019I2024-06-10
04571225314204STERiJECT TMHPC-27019I2024-06-10
04571225314235STERiJECT TMHPC-30013I2024-06-10
04571225317779STERiJECT TMHPC-23013I2024-06-10
04571225317793STERiJECT TMHPC-27013I2024-06-10
04571225317809STERiJECT TMHPC-27019I2024-06-10
04571225317816STERiJECT TMHPC-29010E2024-06-10
04571225317823STERiJECT TMHPC-29013E2024-06-10
04571225317830STERiJECT TMHPC-30013I2024-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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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
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08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03