Miracu BI

GUDID 38809407786165

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID38809407786165
NIH Device Record Key40c83588-97d3-4979-980a-9a13ceab32af
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiracu BI
Version Model NumberMiracu BI 21Gx60mm
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
GS108809407786164 [Unit of Use]
GS118809407786161 [Primary]
GS128809407786168 [Package]
Contains: 18809407786161
Package: [10 Units]
In Commercial Distribution
GS138809407786165 [Package]
Contains: 28809407786168
Package: [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 Date2019-09-01

On-Brand Devices [Miracu BI]

38809407786189Miracu BI 23Gx90mm
38809407786172Miracu BI 23Gx60mm
38809407786165Miracu BI 21Gx60mm

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