LOCalizer

GUDID 10855436007133

Tag Applicator S, 7 cm, Single

HEALTH BEACONS INC

Imaging lesion localization marker, implantable
Primary Device ID10855436007133
NIH Device Record Key277dd5c7-4074-4c3e-8d75-811b4c0ee54e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOCalizer
Version Model NumberHB300-07
Company DUNS080545263
Company NameHEALTH BEACONS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter
Length7 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855436007136 [Primary]
GS110855436007133 [Package]
Contains: 00855436007136
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-02
Device Publish Date2020-02-23

On-Brand Devices [LOCalizer]

10855436007065Tag Applicator 5 cm, Single
10855436007058Tag Applicator 7 cm, Single
10855436007041Tag Applicator 10 cm, Single
00855436007037Reader, Single
10855436007027Tag Applicator, Single
10855436007010Surgical Probe, Single
10855436007140Tag Applicator S, 5 cm, Single
10855436007133Tag Applicator S, 7 cm, Single
10855436007126Tag Applicator S, 10 cm, Single

Trademark Results [LOCalizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOCALIZER
LOCALIZER
88363859 not registered Live/Pending
Faxitron Bioptics, LLC
2019-03-29
LOCALIZER
LOCALIZER
86697210 not registered Dead/Abandoned
Opal Labs Inc.
2015-07-17
LOCALIZER
LOCALIZER
85233789 4141100 Dead/Cancelled
Commercestream Corp.
2011-02-03
LOCALIZER
LOCALIZER
76289398 2648857 Dead/Cancelled
Radio Frequency Systems, Inc.
2001-07-24
LOCALIZER
LOCALIZER
76090984 not registered Dead/Abandoned
Platinum Images
2000-07-18
LOCALIZER
LOCALIZER
73689945 1525323 Dead/Cancelled
S.D.T. INTERNATIONAL, S.A.
1987-10-16

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