FDA.reportPublic FDA data

ATA-CUT

Primary DI
18033959222307
Brand
ATA-CUT
Company
STERYLAB SRL
Model
ATA-CUT
Catalog number
ATC1920
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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
18033959222307PackageGS115In Commercial Distribution
08033959222300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803395922230718033959222307
08033959222300080339592223008033959222300

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
439659574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295020589InradInradKNW2026-10-09
00817295021081InradInradKNW2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021388InradInradKNW2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15