Injection Filter Needle

Injection Filter Needle
Terumo - NF-3013RBKE05M

A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

• Needle Gauge: 30 Gauge
• Needle Length: 0.5 Inch
• Needle Outer Diameter: 0.3 Millimeter
• Needle Length: 12 Millimeter
• Pore size: 5 Micrometer
• Extra thin wall

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QYM

Device Name: Ophthalmic Needle

Device Class: 2

Physical State: sterile hypodermic needles

Definition: An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: An Ophthalmic Needle is to be used to inject fluids into or withdraw fluids from the eye.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device is intended for injections into the eye.

Regulation Number: 880.5570

Third Party Flag: N

Medical Specialty: HO

Device Id: 35413206251224

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05413206251223

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelf box

Device Id: 05413206251223

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 55413206251228

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35413206251224

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton