Miracu BI 21Gx90mm

GUDID 38809407786790

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID38809407786790
NIH Device Record Key213004e0-5e5b-42c7-84dd-8eafc42d29ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiracu BI 21Gx90mm
Version Model Number2190-501GD
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
GS108809407786799 [Unit of Use]
GS118809407786796 [Primary]
GS128809407786793 [Package]
Contains: 18809407786796
Package: INBOX [10 Units]
In Commercial Distribution
GS138809407786790 [Package]
Contains: 28809407786793
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-05
Device Publish Date2019-12-24

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