Rejubeau Stylish FCN 4D 21G x 90mm (W-shape)

GUDID 28800145507879

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID28800145507879
NIH Device Record Keyd343e243-7eef-4be8-961b-72287ce78f9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRejubeau Stylish FCN 4D 21G x 90mm (W-shape)
Version Model NumberW4-FTN2192G
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
GS108800145507875 [Unit of Use]
GS118800145507872 [Primary]
GS128800145507879 [Package]
Contains: 18800145507872
Package: inbox [10 Units]
In Commercial Distribution
GS138800145507876 [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 Date2023-12-28
Device Publish Date2023-12-20

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