VitreJect Ophthalmic Needle

Primary DI
00855265008922
Brand
VitreJect Ophthalmic Needle
Company
Ocuject, LLC
Model
PN0407-03
Device description
The VitreJect® LDS Safety Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The VitreJect® LDS Safety Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needles are suitable for intravitreal use.
Published
2025-02-28
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

Contact Domains#

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
K242956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242956000LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC2024-10-25QNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855265008922PackageGS1100In Commercial Distribution
00855265008939PackageGS11000In Commercial Distribution
00855265008915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855265008922008552650089228552650089220855265008922
00855265008939008552650089398552650089390855265008939
00855265008915008552650089158552650089150855265008915

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 721-6716support@ocuject.com

Regulatory Flags#

DUNS number
017559643
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
false
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
00855265008540VitreJect-DS SyringePN0208-012023-09-08
00850037925940VitreJect Ophthalmic SyringePN0209-122025-02-28
00850040387360VitreJect-DL Ophthalmic NeedlePN0625-032025-02-28
00855265008854VitreJect Ophthalmic SyringePN0209-112025-02-28
00855265008861VitreJect Ophthalmic NeedlePN0407-012025-02-28
00855265008885VitreJect Ophthalmic NeedlePN0407-042025-02-28
00855265008915VitreJect Ophthalmic NeedlePN0407-032025-02-28
00850037925957VitreJect Ophthalmic SyringePN0209-122025-02-28
00850040387377VitreJect-DL Ophthalmic NeedlePN0625-032025-02-28
00855265008038VitreJect Ophthalmic NeedlePN0404-032025-02-28
00850037925834VitreJect Ophthalmic SyringePN0209-112025-02-28
10855265008868VitreJect Ophthalmic NeedlePN0407-012025-02-28
00855265008892VitreJect Ophthalmic NeedlePN0407-042025-02-28
00850037925629OcuSafe-XL Ophthalmic NeedlePN0403-152024-12-16
00850040387391VitreJect-DL Ophthalmic NeedlePN0625-042024-12-16
00850040387421VitreJect-DL Ophthalmic NeedlePN0625-012024-12-16
00850047046468VitreJect-DLX Ophthalmic NeedlePN0625-132024-12-16
00850047046529OcuSafe Ophthalmic NeedlePN0403-242024-12-16
00855265008007VitreJect Ophthalmic NeedlePN0404-012024-12-16
00855265008021VitreJect Ophthalmic NeedlePN0404-042024-12-16

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
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
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