FDA.reportPublic FDA data

VitreJect Syringe

Primary DI
00850040387926
Brand
VitreJect Syringe
Company
Ocuject, LLC
Model
PN0208-01
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
2023-09-08
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040387926PackageGS11000In Commercial Distribution
00855265008540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040387926008500403879268500403879260850040387926
00855265008540008552650085408552650085400855265008540

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.

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
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
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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
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