Rejubeau Fine Meso Needle 34G x 8mm

GUDID 28800145508685

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID28800145508685
NIH Device Record Keyfeaa9587-1696-4ee7-817b-7b89fa6f1050
Commercial Distribution StatusIn Commercial Distribution
Brand NameRejubeau Fine Meso Needle 34G x 8mm
Version Model NumberFDND 57
Company DUNS688432407
Company NameFeeltech Co.,Ltd.
Device Count100
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
GS108800145508681 [Unit of Use]
GS118800145508688 [Primary]
GS128800145508685 [Package]
Contains: 18800145508688
Package: outbox [1000 Units]
In Commercial Distribution
GS138800145508682 [Package]
Package: carton box [5000 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 Date2024-05-17
Device Publish Date2024-05-09

Devices Manufactured by Feeltech Co.,Ltd.

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