V SOFT LINE ARTE3 17GGx70mm

GUDID 38809407786899

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament
Primary Device ID38809407786899
NIH Device Record Keyc8ea2b15-92fd-4096-bc7c-965e114f1b8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameV SOFT LINE ARTE3 17GGx70mm
Version Model NumberUCA17071520G
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
GS108809407786898 [Unit of Use]
GS118809407786895 [Primary]
GS128809407786892 [Package]
Contains: 18809407786895
Package: INBOX [10 Units]
In Commercial Distribution
GS138809407786899 [Package]
Contains: 28809407786892
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 Date2020-02-03
Device Publish Date2020-01-26

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