HMC-Anomaloskop (R)

GUDID 04049584006967

HMC-Anomaloskop (R)

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Anomaloscope
Primary Device ID04049584006967
NIH Device Record Keye717ec1b-4d1a-4519-8531-02a6120a7448
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMC-Anomaloskop (R)
Version Model Number47720
Company DUNS317138956
Company NameOCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104049584006967 [Primary]

FDA Product Code

HIWAnomaloscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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04049584029454 - BIOM ready+ 200, for f=200 mm2024-09-19 BIOM ready+ 200, for f=200 mm
04049584001450 - BK 1/W, coated, wall version, trial lens case2024-09-12 BK 1/W, coated, wall version, trial lens case
04049584001467 - BK 1/W, without convex cylinders, wall version, trial lens case2024-09-12 BK 1/W, without convex cylinders, wall version, trial lens case
04049584001474 - BK 1/W, without convex cylinders, coated, wall version, trial lens case2024-09-12 BK 1/W, without convex cylinders, coated, wall version, trial lens case
04049584001498 - BK 2, coated, wooden case with handle2024-09-12 BK 2, coated, wooden case with handle
04049584001511 - BK 2, without convex cylinders, wooden case with handle2024-09-12 BK 2, without convex cylinders, wooden case with handle
04049584001528 - BK 2, without convex cylinders, coated,wooden case with handle2024-09-12 BK 2, without convex cylinders, coated,wooden case with handle

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