FDA.reportPublic FDA data

FAST-CUT B

Primary DI
08033959220672
Brand
FAST-CUT B
Company
STERYLAB SRL
Model
FAST-CUT B
Catalog number
FSC2020B
Device description
Biopsy needle for automatic gun 20G; 20cm
Published
2019-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051506000MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSYSterylab S.R.L.2005-07-27FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033959220679PackageGS125In Commercial Distribution
08033959220672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803395922067918033959220679
08033959220672080339592206728033959220672

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun needleAn invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.

Regulatory Flags#

DUNS number
439659574
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033959221990PACPACPAC1020302019-10-03
08033959222003PAC-UFPAC-UFPACUF10202019-10-03
08033959222294ATA-CUTATA-CUTATC19152019-10-16
08033959222300ATA-CUTATA-CUTATC19202019-10-16
08033959222317ATA-CUTATA-CUTATC18112019-10-16
08033959222362ATA-CUTATA-CUTATC16092019-10-16
08033959222386ATA-CUTATA-CUTATC16202019-10-16
08033959222393ATA-CUTATA-CUTATC18092019-10-16
08033959222409ATA-CUTATA-CUTATC18152019-10-16
08033959222416ATA-CUTATA-CUTATC18202019-10-16
08033959222423ATA-CUTATA-CUTATC19092019-10-16
08033959222430ATA-CUTATA-CUTATC19112019-10-16
08033959222447ATA-CUTATA-CUTATC20092019-10-16
08033959222454ATA-CUTATA-CUTATC20112019-10-16
08033959222461ATA-CUTATA-CUTATC20152019-10-16
08033959222478ATA-CUTATA-CUTATC20202019-10-16
08033959222485ATA-CUTATA-CUTATC21112019-10-16
08033959222492ATA-CUTATA-CUTATC21152019-10-16
08033959222768ATA-CUTATA-CUTATC21092019-10-16
08033959225103ATA-CUTATA-CUTATC17202019-10-16

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Primary DI, Brand, Company table
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00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
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