ELASTY Mesoneedle 34Gx8mm

GUDID 38809407786578

Feeltech Co.,Ltd.

Hypodermic needle, single-use
Primary Device ID38809407786578
NIH Device Record Keybe213e87-2b21-42d5-b0da-5b3c65daf71d
Commercial Distribution StatusIn Commercial Distribution
Brand NameELASTY Mesoneedle 34Gx8mm
Version Model NumberFDN 57
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809407786577 [Unit of Use]
GS118809407786574 [Primary]
GS128809407786571 [Package]
Contains: 18809407786574
Package: [1000 Units]
In Commercial Distribution
GS138809407786578 [Package]
Contains: 28809407786571
Package: [5000 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 Date2019-11-13
Device Publish Date2019-11-05

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