What is FDA product code QNS?

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

General Hospital › TherapeuticLow Dead Space Needle, Single Lumen, Hypodermic

OcuSafe-XL Ophthalmic Needle

Name: OcuSafe-XL Ophthalmic Needle
Brand: OcuSafe-XL Ophthalmic Needle

The OcuSafe® LDS Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space…

Registry build 21.09.26

The OcuSafe® LDS Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The OcuSafe® LDS Needles have a removable cap that is removed prior to the needle’s use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The OcuSafe® LDS Needles are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The OcuSafe® LDS Needles are suitable for intravitreal use.

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (1), Shanghai (1).

Chinese manufacturers registered for FDA product code QNS
Manufacturer	City	Province	Registered as	Device types
Zhejiang Kindly Medical Devices Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	16
Shanghai Mekon Medical Devices Co., Ltd.	Shanghai	Shanghai	Exporter	11

Record

Regulatory record for OcuSafe-XL Ophthalmic Needle
Listed by	Ocuject, LLC, United States
FDA product code	QNS
Device type	Low Dead Space Needle, Single Lumen, Hypodermic
Device class	Class 2
Regulation	21 CFR 880.5570
Establishment	Specification developer, Manufacturer
510(k)	K242956
Record published	2024-12-16

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Inner pack of 100, shipping box of 5000

Catalogue Numbers

Catalogue numbers for OcuSafe-XL Ophthalmic Needle
Catalogue number	Size	Status
PN0403-15		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
OcuSafe Ophthalmic Needle	Ocuject, LLC	4
VitreJect Ophthalmic Needle	Ocuject, LLC	2
VitreJect-DL Ophthalmic Needle	Ocuject, LLC	2
VitreJect-DLX Ophthalmic Needle	Ocuject, LLC	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242956	2024-10-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.