AMI Custom Crafted FCL | 21G x 90mm

GUDID 28809407788476

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID28809407788476
NIH Device Record Key4a5c8c1e-ea6e-4d82-9943-bbf429aa5d11
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMI Custom Crafted FCL | 21G x 90mm
Version Model NumberL-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
GS108809407788472 [Unit of Use]
GS118809407788479 [Primary]
GS128809407788476 [Package]
Contains: 18809407788479
Package: INBOX [10 Units]
In Commercial Distribution
GS138809407788473 [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 Date2021-03-01
Device Publish Date2021-02-19

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