LOCalizer

GUDID 00855436007037

Reader, Single

HEALTH BEACONS INC

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID00855436007037
NIH Device Record Key2578ceab-1065-477b-a43d-34e4cf3afba7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOCalizer
Version Model NumberHB100
Company DUNS080545263
Company NameHEALTH BEACONS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855436007037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable
PBYTemporary Tissue Marker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-06-16

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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