LOCalizer

Primary DI
00855436007013
Brand
LOCalizer
Company
HEALTH BEACONS, INC.
Model
HB110
Device description
Surgical Probe, Single
Published
2017-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBYTemporary Tissue Marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBYTemporary Tissue MarkerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855436007010PackageGS15In Commercial Distribution
00855436007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085543600701010855436007010
00855436007013008554360070138554360070130855436007013

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 radiographic film or digital 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
033275602
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855436007020LOCalizerHB2002017-06-16
00855436007044LOCalizerHB200-102018-05-03
00855436007051LOCalizerHB200-072018-05-03
00855436007068LOCalizerHB200-052018-05-03
00855436007129LOCalizerHB300-102020-02-23
00855436007136LOCalizerHB300-072020-02-23
00855436007143LOCalizerHB300-052020-02-23
00855436007037LOCalizerHB1002017-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719992742516Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742509Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
10855436007041LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007058LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007065LOCalizerHEALTH BEACONS INCPBY2018-05-03
00852205006017SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006024SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006031SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006048SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006093SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
10852205006014SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006055SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006062SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006079SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006086SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
10852205006090SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00855436007020LOCalizerHEALTH BEACONS, INC.PBY2017-06-16
10855436007010LOCalizerHEALTH BEACONS INCPBY2017-06-16
10855436007027LOCalizerHEALTH BEACONS INCPBY2017-06-16
00855436007037LOCalizerHEALTH BEACONS, INC.PBY2017-06-16