Miracu FCL FORTE FIX 19Gx70mm

GUDID 28800145503420

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID28800145503420
NIH Device Record Key72bada88-f5d1-4932-8a6f-8e8fb9def181
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiracu FCL FORTE FIX 19Gx70mm
Version Model Number3FX19071601GA
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 Datetrue
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
GS108800145503426 [Unit of Use]
GS118800145503423 [Primary]
GS128800145503420 [Package]
Contains: 18800145503423
Package: INBOX [10 Units]
In Commercial Distribution
GS138800145503427 [Package]
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 Date2022-06-02
Device Publish Date2022-05-25

Devices Manufactured by Feeltech Co.,Ltd.

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