FAST-CUT PLUS FSC1415+

GUDID 18033959223939

Biopsy needle for automatic gun 14G; 15cm

STERYLAB SRL

End-cut biopsy gun needle
Primary Device ID18033959223939
NIH Device Record Key0732d394-9323-42e7-8282-bd91e7ece616
Commercial Distribution StatusIn Commercial Distribution
Brand NameFAST-CUT PLUS
Version Model NumberFAST-CUT PLUS
Catalog NumberFSC1415+
Company DUNS439659574
Company NameSTERYLAB SRL
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033959223932 [Primary]
GS118033959223939 [Package]
Contains: 08033959223932
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-11
Device Publish Date2019-10-02

Devices Manufactured by STERYLAB SRL

18033959222291 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
18033959222307 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
18033959222314 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
08033959222324 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
18033959222369 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
08033959222379 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
18033959222383 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm
18033959222390 - ATA-CUT2019-10-24 Menghini modified needle for soft tissue biopsy 16G; 9 cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.