FDA.reportPublic FDA data

Breast localisation needle

Primary DI
04260277173074
Brand
Breast localisation needle
Company
Möller Medical GmbH
Model
BLM-1130-20-0125
Published
2018-08-17
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
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
04260277173128PackageGS110In Commercial Distribution
04260277173074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277173128042602771731284260277173128
04260277173074042602771730744260277173074

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile 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 formed as a wire, needle, bead, stent-like tube or washer, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320405061
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04260632794043TLA Tubing Liposat Pro plus000039972026-02-27
04260632790502Spatula Double-Hole CannulaASC-S820-25-01502019-05-07
04260632790526Spatula Triple-Hole CannulaASC-S830-25-01502019-05-07
04260632790564Tumescence Infiltration CannulaASC-S910-20-01502019-05-07
04260632790595Tumescence Infiltration CannulaASC-S910-25-02502019-05-07
04260632792117Spatula Single-Hole CannulaASC-S810-30-01502019-05-07
04260277175627Biopsy Kit for 10G Vertebroplasty Needle Kit10001573US03.702.223S2019-07-04
04260277175634Biopsy Kit for 8G Vertebroplasty Needle Kit10001574US03.702.222S2019-07-04
04260632793190Bone marrow biopsy systemBOW-1076-15-00502021-08-18
04260632793206Bone marrow biopsy systemBOW-1076-15-01002021-08-18
04260632793213Bone marrow biopsy systemBOW-1066-08-01002021-08-18
04260632793305Bone marrow biopsy systemBOW-1066-08-01252021-08-18
04260632793312Bone marrow biopsy systemBOW-1066-08-01502021-08-18
04260632793329Bone marrow biopsy systemBOW-1066-11-01002021-08-18
04260632793336Bone marrow biopsy systemBOW-1066-11-01252021-08-18
04260632793343Bone marrow biopsy systemBOW-1066-11-01502021-08-18
04260632793350Bone marrow biopsy systemBOW-1066-13-00622021-08-18
04260632793367Bone marrow biopsy systemBOW-1066-13-01002021-08-18
04260277177775icotec Instrument Cement Cannula1000211942-4202020-10-23
04260632792308Liposat Pro plus000039742020-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253036877MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036880MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036897MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036907MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036934MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036941MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036952MonojectCardinal Health 200, LLCGAA2026-03-23
50198956355451CARDINAL HEALTHCardinal Health 200, LLCGAA2026-03-19
MHC18018250EasyTouchMHC MEDICAL PRODUCTS, LLCGAA2026-03-17
00810235030860US Accessory KitMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030877US Rigid Needle with Support Cannula- Double BevelMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030884US Rigid Injection Needle with Huber PointMERZ NORTH AMERICA, INC.GAA2026-03-05
20850083784403Comfort EZS.D.I. USA, INC.GAA2026-02-13
50192253036860MonojectCardinal Health 200, LLCGAA2026-02-10
50192253036976MonojectCardinal Health 200, LLCGAA2026-02-10
50192253025260MonojectCardinal Health 200, LLCGAA2026-01-16
50198956310047CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-26
50198956290554CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-17
50198956168808CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-11
04046964941245Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-09
06938695502155Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
06938695527004Bone DrillShanghai Kinetic Medical Co., Ltd.GAA2025-12-09
04046964943232NAB. BRAUN MEDICAL INC.GAA2025-12-02
04046964941221Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-02
50198956273182CARDINAL HEALTHCardinal Health 200, LLCGAA2025-11-14
04250676736109VoiceInject injection needleSpiggle & Theis Medizintechnik GmbHGAA2025-09-09
08800176592673WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592680WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592697WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592703WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08