VitreJect Ophthalmic Syringe

Primary DI
00850037925957
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
OTC
false
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.

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
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
00850037925940VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00855265008854VitreJect 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