FDA.reportPublic FDA data

Beacon

Primary DI
00855208005162
Brand
Beacon
Company
Covidien LP
Model
F-19-05
Device description
BNX Fine Needle Fiducial Needle
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152586000Beacon Fine Needle Fiducial SystemCovidien, LLC2015-12-30NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855208005169PackageGS15In Commercial Distribution
00855208005162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085520800516910855208005169
00855208005162008552080051628552080051620855208005162

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge19Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521032903BiosynGMT-2262015-09-01
10884521102163Vascufil88864788-05V2015-08-31
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103653HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2026-07-07
00841911102939HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103110HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103554HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103561HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103578HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103523HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103547HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103479HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103486HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103493HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103509HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103516HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103370HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103387HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103394HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103400HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103417HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103424HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103431HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103448HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103455HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103462HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103318HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103325HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103332HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103349HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103356HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103363HydroMarkDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01