Feelsoft Micro Needles

Basic Information

• Brand Name: Feelsoft Micro Needles
• Primary DI: 18809407787670
• Version / Model: Feelsoft Micro Mesoneedles 33Gx4mm
• Company Name: Feeltech Co.,Ltd.
• Labeler DUNS: 688432407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 1
• Public Version Date: 2020-08-04
• Public Version Status: New
• Public Device Record Key: ab0dcf7c-61ef-490b-831b-20742828e13b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
FMI	Needle, Hypodermic, Single Lumen	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28809407787677	GS1	OUTBOX	800	In Commercial Distribution
Primary	18809407787670	GS1
Package	38809407787674	GS1	CARTONBOX	4000	In Commercial Distribution
Unit of Use	08809407787673	GS1

Premarket Submissions

Submission Number	Supplement Number
K092831	000