FDA.reportPublic FDA data

Breast Localization Needles

Primary DI
00886333003754
Brand
Breast Localization Needles
Company
ARGON MEDICAL DEVICES, INC.
Model
244075
Catalog number
244075
Device description
Hawkins™ III Hardwire BLN with Echogenic Tip 20ga x 7.5cm
Published
2022-06-29
Public version status
Update
Distribution status
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
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333003758PackageGS110In Commercial Distribution
00886333003754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300375820886333003758
00886333003754008863330037548863330037540886333003754

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
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05
00886333003808Breast Localization Needles2511252511252022-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456802Medco ManufacturingMedco Manufacturing LLCGDM2026-08-25
00810130456772Medco ManufacturingMedco Manufacturing LLCGDM2026-08-07
14026704760555PILLINGTELEFLEX INCORPORATEDGDM2026-07-31
00810130456543Medco ManufacturingMedco Manufacturing LLCGDM2026-06-26
00348783011340Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011357Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011364Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00348783011371Premier Needle AdapterPREMIER DENTAL PRODUCTS COMPANYGDM2026-06-10
00810130456499Medco ManufacturingMedco Manufacturing LLCGDM2026-06-05
00840516145884Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2026-06-02
00810130456376Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456383Medco ManufacturingMedco Manufacturing LLCGDM2026-05-29
00810130456307Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456345Medco ManufacturingMedco Manufacturing LLCGDM2026-05-07
00810130456260Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456277Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130456284Medco ManufacturingMedco Manufacturing LLCGDM2026-04-16
00810130455645Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455744Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455799Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455805Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455874Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455881Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455898Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455942Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455959Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130455966Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456048Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456055Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31
00810130456079Medco ManufacturingMedco Manufacturing LLCGDM2026-03-31