Pentacam HR

GUDID 04049584000026

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Corneal topography system
Primary Device ID04049584000026
NIH Device Record Key1a5dbe42-41c8-41ef-810f-eb604660b711
Commercial Distribution StatusIn Commercial Distribution
Brand NamePentacam HR
Version Model Number70900
Company DUNS317138956
Company NameOCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height535 Millimeter
Depth360 Millimeter
Width280 Millimeter
Weight11 Kilogram

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
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104049584000026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXKDevice,Analysis,Anterior Segment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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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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