Rejubeau N.Double FORTE 19G x 60mm

GUDID 28800145513696

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID28800145513696
NIH Device Record Key35ed4578-3645-4ff4-8089-c03d3cc638f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRejubeau N.Double FORTE 19G x 60mm
Version Model Number3DA19601202G
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
GS108800145513692 [Unit of Use]
GS118800145513699 [Primary]
GS128800145513696 [Package]
Contains: 18800145513699
Package: inbox [10 Units]
In Commercial Distribution
GS138800145513693 [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 Date2024-10-24
Device Publish Date2024-10-16

Devices Manufactured by Feeltech Co.,Ltd.

28800145513696 - Rejubeau N.Double FORTE 19G x 60mm2024-10-24
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28800145513719 - Rejubeau FCL FORTE 19G x 70mm2024-10-24
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28800145513375 - REJUBEAU FCN 4D 19G x 100mm (W-shape)2024-07-18
28800145513382 - REJUBEAU FCN 4D 21G x 60mm (W-shape)2024-07-18
28800145508340 - IDryNeedle 0.25x302024-05-17
28800145508357 - IDryNeedle 0.25x402024-05-17

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