FDA.reportPublic FDA data

VitreJect Syringe

Primary DI
00850047046147
Brand
VitreJect Syringe
Company
Ocuject, LLC
Model
PN0288-01
Device description
The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
Published
2023-08-31
Public version status
Update
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047046154PackageGS1100In Commercial Distribution
00850047046161PackageGS11000In Commercial Distribution
00850047046147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047046154008500470461548500470461540850047046154
00850047046161008500470461618500470461610850047046161
00850047046147008500470461478500470461470850047046147

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02