FDA.reportPublic FDA data

Breast Localization Needles

Primary DI
00886333007585
Brand
Breast Localization Needles
Company
ARGON MEDICAL DEVICES, INC.
Model
BLND2015
Catalog number
BLND2015
Device description
D Wire BLN 20ga x 15cm
Published
2022-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
20886333007589PackageGS110Not in Commercial Distribution
00886333007585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300758920886333007589
00886333007585008863330075858863330075850886333007585

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
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
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
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08