V SOFT LINE BARB STAR 21Gx60mm

GUDID 38809407787001

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament
Primary Device ID38809407787001
NIH Device Record Keybcb22ed9-c680-4284-b7c1-a4e4e3d03b01
Commercial Distribution StatusIn Commercial Distribution
Brand NameV SOFT LINE BARB STAR 21Gx60mm
Version Model Number2160-101GD
Company DUNS688432407
Company NameFeeltech Co.,Ltd.
Device Count10
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
GS108809407787000 [Unit of Use]
GS118809407787007 [Primary]
GS128809407787004 [Package]
Contains: 18809407787007
Package: INBOX [10 Units]
In Commercial Distribution
GS138809407787001 [Package]
Contains: 28809407787004
Package: CARTON BOX [300 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSuture, Surgical, Absorbable, Polydioxanone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-26

Devices Manufactured by Feeltech Co.,Ltd.

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