VitreJect-DL Ophthalmic Needle

Primary DI
00850040387421
Brand
VitreJect-DL Ophthalmic Needle
Company
Ocuject, LLC
Model
PN0625-01
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
2024-12-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNSLow Dead Space Needle, Single Lumen, Hypodermic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNSLow Dead Space Needle, Single Lumen, HypodermicGeneral 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
00850040387438PackageGS1100In Commercial Distribution
00850040387445PackageGS15000In Commercial Distribution
00850040387421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040387438008500403874388500403874380850040387438
00850040387445008500403874458500403874450850040387445
00850040387421008500403874218500403874210850040387421

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.

Contacts#

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

Regulatory Flags#

DUNS number
017559643
Device count
1
Lot or batch
true
Expiration date on label
true

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
00855265008922VitreJect Ophthalmic NeedlePN0407-032025-02-28
00850037925629OcuSafe-XL Ophthalmic NeedlePN0403-152024-12-16
00850040387391VitreJect-DL Ophthalmic NeedlePN0625-042024-12-16
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
00850037925629OcuSafe-XL Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00850040387391VitreJect-DL Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00850047046468VitreJect-DLX Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00850047046529OcuSafe Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00855265008007VitreJect Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00855265008021VitreJect Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00855265008557OcuSafe Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00855265008564OcuSafe Ophthalmic NeedleOcuject, LLCQNS2024-12-16
00855265008786OcuSafe Ophthalmic NeedleOcuject, LLCQNS2024-12-16