FDA.reportPublic FDA data

Fullcore Biopsy Needle

Primary DI
04260277174675
Brand
Fullcore Biopsy Needle
Company
Möller Medical GmbH
Model
DNG-2020-14-0200
Published
2018-08-17
Public version status
Update
Distribution status
Not 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
KNWInstrument, Biopsy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277174705PackageGS110Not in Commercial Distribution
04260277174675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277174705042602771747054260277174705
04260277174675042602771746754260277174675

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
320405061
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260632793640TLA Tubing Liposat Pro plus000039972026-02-27
04260632794043TLA Tubing Liposat Pro plus000039972026-02-27
04260632792339TLA Tubing Liposat Pro plus000039972020-01-21
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260632791622Basket Cannula 2.0ASC-R520-30-02502019-05-09
04260632791639Basket Cannula 2.0ASC-R520-30-03502019-05-09
04260632791646Basket Cannula 2.0ASC-R520-40-02502019-05-09
04260632791660Basket Cannula 2.0ASC-R520-50-02502019-05-09
04260632791677Basket Cannula 2.0ASC-R520-50-03502019-05-09
04260632791684Basket Cannula 2.0ASC-R521-30-02502019-05-09
04260632791691Basket Cannula 2.0ASC-R521-30-03502019-05-09
04260632791707Basket Cannula 2.0ASC-R521-40-02502019-05-09
04260632791721Basket Cannula 2.0ASC-R521-50-02502019-05-09
04260632790151Basket Cannula 2.0ASC-S520-40-03502019-05-06
04260632790168Basket Cannula 2.0ASC-S520-50-02502019-05-06
04260632790175Basket Cannula 2.0ASC-S520-50-03502019-05-06
04260632790182Basket Cannula 2.0ASC-S521-30-02502019-05-06
04260632790205Basket Cannula 2.0ASC-S521-40-02502019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450831554Tru-Cut®Merit Medical Systems, Inc.KNW2026-07-08
00884450397961TEMNO Elite™Merit Medical Systems, Inc.KNW2026-06-10
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-06-09
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
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