Feelsoft Micro Needles

GUDID 28809407787677

Feeltech Co.,Ltd.

Hypodermic needle, single-use
Primary Device ID28809407787677
NIH Device Record Keyab0dcf7c-61ef-490b-831b-20742828e13b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFeelsoft Micro Needles
Version Model NumberFeelsoft Micro Mesoneedles 33Gx4mm
Company DUNS688432407
Company NameFeeltech Co.,Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809407787673 [Unit of Use]
GS118809407787670 [Primary]
GS128809407787677 [Package]
Contains: 18809407787670
Package: OUTBOX [800 Units]
In Commercial Distribution
GS138809407787674 [Package]
Package: CARTONBOX [4000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

Devices Manufactured by Feeltech Co.,Ltd.

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