FDA.reportPublic FDA data

STERiJECT TM

Primary DI
04571225316116
Brand
STERiJECT TM
Company
TSK LABORATORY, JAPAN
Model
PRE-23019
Device description
TSK STERiJECT Premium Disposable Hypodermic Needle
Published
2017-09-11
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
14571225316113PackageGS160In Commercial Distribution
04571225316116PrimaryGS10
04571225316109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1457122531611314571225316113
04571225316116045712253161164571225316116
04571225316109045712253161094571225316109

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
Length19Millimeter
Outer Diameter0.6Millimeter

Regulatory Flags#

DUNS number
716217877
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
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

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