PAC PAC102030

GUDID 08033959221990

Reusable pistol for cytological aspiration

STERYLAB SRL

Biopsy gun handpiece
Primary Device ID08033959221990
NIH Device Record Keyce20e8f7-78ab-422c-874d-86479919fa8e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePAC
Version Model NumberPAC
Catalog NumberPAC102030
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033959221990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-11
Device Publish Date2019-10-03

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

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