VitreJect Ophthalmic Syringe

GUDID 00850037925834

The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

Ocuject, LLC

General-purpose syringe, single-use
Primary Device ID00850037925834
NIH Device Record Keyd4464214-c702-42a5-a55f-d0acad9e67d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitreJect Ophthalmic Syringe
Version Model NumberPN0209-11
Company DUNS017559643
Company NameOcuject, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com
Phone(949) 721-6716
Emailsupport@ocuject.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037925834 [Package]
Contains: 00855265008854
Package: Inner Pack [250 Units]
In Commercial Distribution
GS100850037925841 [Package]
Package: Shipping Box [1000 Units]
In Commercial Distribution
GS100855265008854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QLYOphthalmic Syringe

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-10
Device Publish Date2025-02-28

On-Brand Devices [VitreJect Ophthalmic Syringe]

00850037925834The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The
00850037925957The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The

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