FDA.reportPublic FDA data

Breast Localization Needles

Primary DI
20886333003741
Brand
Breast Localization Needles
Company
ARGON MEDICAL DEVICES, INC.
Model
244050
Catalog number
244050
Device description
Hawkins™ III Hardwire BLN with Echogenic Tip 20ga x 5cm
Published
2022-06-30
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

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
20886333003741PackageGS110In Commercial Distribution
00886333003747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300374120886333003741
00886333003747008863330037478863330037470886333003747

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization 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 formed as a wire, needle, bead, clip, 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.

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

Sterilization Methods#

Method table
Method

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
20886333227864V-Stick Vascular Access Set391504300E391504300E2026-03-20
20886333227871V-Stick Vascular Access Set391505300E391505300E2026-03-20
20886333227888V-Stick Vascular Access Set 391505400E391505400E2026-03-20
20886333227895V-Stick Vascular Access Set391604300E391604300E2026-03-20
20886333227901V-Stick Vascular Access Set 391605300E391605300E2026-03-20
20886333227918V- Stick Vascular Access Set391605400E391605400E2026-03-20
20886333227925V-Stick Vascular Access Set391504400E391504400E2026-03-20
20886333227932V-Stick Vascular Access Set391604400E391604400E2026-03-20
20886333209259Tumescent Infiltration Kit1981431981432025-05-02
10886333227584OneStic Micro-Access Introducer4978864978862025-05-02
20886333227116Bone Access NeedleDBANJ0806TLDBANJ0806TL2023-01-03
20886333227659Transfermoral Transcaval Liver Biopsy SystemTF-18CTF-18C2024-08-12
20886333227499ClosureFast GuidewireGW-025-260-1.5JGW-025-260-1.5J2024-07-29
20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
20886333227529ClosureFast Introducer Sheath IS-7F11IS-7F112024-07-29
20886333227550ClosureFast Micro Puncture MPK-4FMPK-4F2024-07-29
20886333227567ClosureFast Micro PunctureMPK-5FMPK-5F2024-07-29
20886333227574ClosureFast Tumescent Infiltration KitTIK-01TIK-012024-07-29
20886333227444ClosureFast Arterial NeedleAN-19GEAN-19GE2024-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLEW.H. Holden, Inc.GDM2026-01-15
04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
04059453124135Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-08-25
00810130455386Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00810130455393Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00194613120238MSI Precision Specialty InstrumentsMed Saver, Inc.GDM2025-08-01
00810130455300Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455317Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455324Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455331Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455218Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455225Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455232Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455164Medco ManufacturingMedco Manufacturing LLCGDM2025-06-17
00810130455140Medco ManufacturingMedco Manufacturing LLCGDM2025-06-10
00190776401139MillenniumAvalign Technologies, Inc.GDM2025-06-09
D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
00810130455003Medco ManufacturingMedco Manufacturing LLCGDM2025-05-06
00192896121492Heparin Olive Tip Needle CannulaSONTEC INSTRUMENTS, INC.GDM2025-04-22
00810130454976Medco ManufacturingMedco Manufacturing LLCGDM2025-04-04
00810130454907Medco ManufacturingMedco Manufacturing LLCGDM2025-03-27
00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
00819127023515Tulip Medical Products Reusable CannulasTulip Medical ProductsGDM2025-02-05
00810130454662Medco ManufacturingMedco Manufacturing LLCGDM2024-12-19
00810130454631Medco ManufacturingMedco Manufacturing LLCGDM2024-12-18
D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18