FDA.reportPublic FDA data

Breast Needle Locator

Primary DI
00813079020387
Brand
Breast Needle Locator
Company
REMINGTON MEDICAL, INC.
Model
BNL-2007
Catalog number
BNL-2007
Device description
20ga (0.9mm) x 7cm
Published
2020-09-24
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
MIJNEEDLE, TUMOR LOCALIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020384PackageGS110In Commercial Distribution
20813079020381PackageGS110In Commercial Distribution
00813079020387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902038410813079020384
2081307902038120813079020381
00813079020387008130790203878130790203870813079020387

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
Needle Gauge0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813079020363Breast Needle LocatorBNL-2003BNL-20032020-09-24
00813079020370Breast Needle LocatorBNL-2005BNL-20052020-09-24
00813079020394Breast Needle LocatorBNL-2010BNL-20102020-09-24
00813079021506Remington Medical, Inc Disposable Extension CablePK-155-BPK-155-B2026-04-10
00813079022664VascuChek TransceiverVC-TRX-02VC-TRX-022025-11-27
00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
00813079022008Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022015Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412BNAC-1412B2025-01-17
00813079022022Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416BNAC-1416B2025-01-17
00813079022039Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420BNAC-1420B2025-01-17
00813079022046Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610BNAC-1610B2025-01-17
00813079022053Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616BNAC-1616B2025-01-17
00813079022060Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1620BNAC-1620B2025-01-17
00813079022077Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1810BNAC-1810B2025-01-17
00813079022084Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416NAC-14162025-01-17
00813079022091Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1825NAC-18252025-01-17
00813079022107Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022114Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412MNAC-1412M2025-01-17
00813079022121Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416MNAC-1416M2025-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
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08059174746964MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
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08059174747091MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
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08059174747121MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174746988MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
18059174746985MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
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