BLO-K 812025

GUDID G6358120252

Prostate Anesthesia needle BLO-K

HISTO S.A.

Spinal needle, single-use
Primary Device IDG6358120252
NIH Device Record Key042ea8e0-fdf2-451c-932a-2b285db5dac9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBLO-K
Version Model Number20 Ga x 25 cm
Catalog Number812025
Company DUNS971156914
Company NameHISTO S.A.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR
Phone+540114712541
EmailNICOLAS@HISTO.COM.AR

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG635812025 [Primary]
HIBCCG6358120252 [Package]
Contains: G635812025
Package: BOX [10 Units]
In Commercial Distribution

FDA Product Code

DWONeedle, Biopsy, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-27
Device Publish Date2024-05-17

On-Brand Devices [BLO-K]

G6358120252Prostate Anesthesia needle BLO-K
G6358120202Prostate Anesthesia needle BLO-K

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