FDA.reportPublic FDA data

Breast localisation needle

Primary DI
04260277172862
Brand
Breast localisation needle
Company
Möller Medical GmbH
Model
BLM-1110-20-0100
Published
2018-12-10
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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277172916PackageGS110Not in Commercial Distribution
04260277172862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277172916042602771729164260277172916
04260277172862042602771728624260277172862

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Regulatory Flags#

DUNS number
320405061
Device count
1
Premarket exempt
true
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
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
04260632790229Basket Cannula 2.0ASC-S521-50-02502019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
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08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08