Terumo

Basic Information

• Brand Name: Terumo
• Primary DI: 05413206251223
• Version / Model: NF-3013RBKE05M
• Catalog Number: NF-3013RBKE05M
• Company Name: Terumo Europe NV
• Labeler DUNS: 370193559
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-27
• Public Version: 1
• Public Version Date: 2023-11-06
• Public Version Status: New
• Public Device Record Key: 27c9e135-0d4a-4244-ad31-e8ce160a2e5d

Device Description

Injection Filter Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QYM	Ophthalmic Needle	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	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.	No	Active
47610	Ophthalmic needle, single-use	A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35413206251224	GS1	Shelf box	100	In Commercial Distribution
Primary	05413206251223	GS1
Package	55413206251228	GS1	Carton	30	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230951	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge
Device Size Text, specify			Needle Length: 0.5 Inch
Device Size Text, specify			Needle Outer Diameter: 0.3 Millimeter
Device Size Text, specify			Needle Length: 12 Millimeter
Device Size Text, specify			Pore size: 5 Micrometer
Device Size Text, specify			Extra thin wall

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight. Keep dry.