ELASTY Mesoneedle 33Gx8mm

GUDID 38809407786592

Feeltech Co.,Ltd.

Hypodermic needle, single-use
Primary Device ID38809407786592
NIH Device Record Key437292a1-0bb1-40c3-94af-6f3eb0dd31e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameELASTY Mesoneedle 33Gx8mm
Version Model NumberFDN 55
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809407786591 [Unit of Use]
GS118809407786598 [Primary]
GS128809407786595 [Package]
Contains: 18809407786598
Package: [1000 Units]
In Commercial Distribution
GS138809407786592 [Package]
Contains: 28809407786595
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

Devices Manufactured by Feeltech Co.,Ltd.

28800145507862 - Rejubeau Stylish FCN 4D 19G x 90mm (W-shape)2023-12-28
28800145507879 - Rejubeau Stylish FCN 4D 21G x 90mm (W-shape)2023-12-28
28800145507886 - Rejubeau Stylish FCL Forte 18G x 70mm (L-shape)2023-12-28
28800145507893 - Rejubeau Stylish FCL Forte 19G x 100mm (L-shape)2023-12-28
28800145507909 - Rejubeau Stylish FCN Forte Double 19G x 100mm (W-shape)2023-12-28
28800145507916 - Rejubeau Stylish FCV Line 17G x 100mm2023-12-28
28800145507923 - Rejubeau Stylish FCL Forte Fix 19G x 100mm (L-shape)2023-12-28
28800145507930 - Rejubeau Stylish FCN V UP Shark 19G x 100mm (W-shape)2023-12-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.