FDA.reportPublic FDA data

STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)

Primary DI
04573545740039
Brand
STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)
Company
TSK LABORATORY INTERNATIONAL JAPAN K.K.
Model
VLDS-32004
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QYMOphthalmic Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYMOphthalmic NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242073000STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK2024-10-23QYM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04571603050038PackageGS150In Commercial Distribution
14571603050035PackageGS14800In Commercial Distribution
04573545740039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04571603050038045716030500384571603050038
1457160305003514571603050035
04573545740039045735457400394573545740039

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic needle, single-useA slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.

Regulatory Flags#

DUNS number
717605253
Device count
1
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
04573545740015STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-020092025-07-14
04573545740022STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-330092025-07-14
04573545740046STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320092025-07-14
04573545740053STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320132025-07-14
04573545740060STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-30013E2025-07-14
04573545740077STERiJECT OPHTHALMIC NEEDLE™ VHPC-29010E2025-07-14
04573545740107STERiJECT OPHTHALMIC NEEDLE™ VHPC-29013E2025-07-14
04571603050014STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-020092025-07-14
04571603050021STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-330092025-07-14
04571603050038STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320042025-07-14
04571603050045STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320092025-07-14
04571603050052STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320132025-07-14
04571603050069STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-30013E2025-07-14
04571603050076STERiJECT OPHTHALMIC NEEDLE™ VHPC-29010E2025-07-14
04571603050083STERiJECT OPHTHALMIC NEEDLE™ VHPC-29013E2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573545740015STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740022STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740046STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740053STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740060STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740077STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04573545740107STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050014STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050021STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050038STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050045STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050052STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050069STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050076STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
04571603050083STERiJECT OPHTHALMIC NEEDLE™ TSK LABORATORY INTERNATIONAL JAPAN K.K.QYM2025-07-14
00850040387360VitreJect-DL Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008861VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008885VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008915VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00850040387377VitreJect-DL Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008038VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
10855265008868VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008892VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
00855265008922VitreJect Ophthalmic NeedleOcuject, LLCQYM2025-02-28
05413206251223TerumoTerumo Europe NVQYM2023-10-27
35413206251224TerumoTerumo Europe NVQYM2023-10-27