FDA.reportPublic FDA data

STERiJECT TM

Primary DI
04571225314464
Brand
STERiJECT TM
Company
TSK LABORATORY, JAPAN
Model
PRC-25038ISG
Device description
TSK STERiJECT Premium Disposable Hypodermic Needle
Published
2016-12-23
Public version status
Update
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
04571225314334PackageGS140In Commercial Distribution
14571225314331PackageGS175In Commercial Distribution
14571225314461PackageGS120In Commercial Distribution
04571225314464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04571225314334045712253143344571225314334
1457122531433114571225314331
1457122531446114571225314461
04571225314464045712253144644571225314464

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
Length38Millimeter
Outer Diameter0.5Millimeter

Regulatory Flags#

DUNS number
716217877
Device count
1
Lot or batch
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
04580708067445STERiJECT TMLDS-27006I2025-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
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