OcuSafe Ophthalmic Needle

Primary DI
00855265008786
Brand
OcuSafe Ophthalmic Needle
Company
Ocuject, LLC
Model
PN0403-01
Device description
The OcuSafe® LDS 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 OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS 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
00855265008793PackageGS15000In Commercial Distribution
10855265008783PackageGS1100In Commercial Distribution
00855265008786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855265008793008552650087938552650087930855265008793
1085526500878310855265008783
00855265008786008552650087868552650087860855265008786

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
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

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
00850040387421VitreJect-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