FDA.reportPublic FDA data

ATA-CUT

Primary DI
08033959222409
Brand
ATA-CUT
Company
STERYLAB SRL
Model
ATA-CUT
Catalog number
ATC1815
Device description
Menghini modified needle for soft tissue biopsy 16G; 9 cm
Published
2019-10-16
Public version status
New
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
18033959222406PackageGS115In Commercial Distribution
08033959222409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803395922240618033959222406
08033959222409080339592224098033959222409

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
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
08033959228319ATA-CUTATA-CUTATC17092019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17340179900122EndoDrill Drive System USBibbinstruments ABFCG2026-10-15
00817295020589InradInradKNW2026-10-09
00817295021081InradInradFCG2026-10-08
00817295021081InradInradKNW2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021388InradInradKNW2026-10-08
00817295021388InradInradFCG2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25