VitreJect Ophthalmic Syringe

Primary DI
00850037925940
Brand
VitreJect Ophthalmic Syringe
Company
Ocuject, LLC
Model
PN0209-12
Device description
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.
Published
2025-02-28
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
QLYOphthalmic Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLYOphthalmic SyringeGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230372000VitreJect SyringeOcuject, LLC2023-09-08QLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037925957PackageGS1250In Commercial Distribution
00850037925964PackageGS11000In Commercial Distribution
00850037925940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037925957008500379259578500379259570850037925957
00850037925964008500379259648500379259640850037925964
00850037925940008500379259408500379259400850037925940

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
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
00855265008021VitreJect Ophthalmic NeedlePN0404-042024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855265008854VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00850037925957VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00850037925834VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
B994SC250LL0StaClearStaclear, Inc.QLY2023-09-21
B994SC250AN0StaClearStaclear, Inc.QLY2023-08-16
B994SC250LS0StaClearStaclear, Inc.QLY2022-08-08
B994SC250LS2StaClearTribofilm Research, Inc.QLY2022-08-08
B994SC2500StaClearStaclear, Inc.QLY2020-12-11
B994SC2501StaClearTribofilm Research, Inc.QLY2020-12-11