FDA.reportPublic FDA data

STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)

Primary DI
04571603050052
Brand
STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)
Company
TSK LABORATORY INTERNATIONAL JAPAN K.K.
Model
VLDS-32013
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
04571603050052PackageGS150In Commercial Distribution
14571603050059PackageGS14800In Commercial Distribution
04573545740053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04571603050052045716030500524571603050052
1457160305005914571603050059
04573545740053045735457400534573545740053

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
717605253
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04573545740039STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS)VLDS-320042025-07-14
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
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
04573545740039STERiJECT 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
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