Primary Device ID | 04049584000019 |
NIH Device Record Key | 287d4203-6f29-4cc5-9007-7157e65177f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pentacam |
Version Model Number | 70700 |
Company DUNS | 317138956 |
Company Name | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Weight | 10.5 Kilogram |
Height | 535 Millimeter |
Depth | 360 Millimeter |
Width | 280 Millimeter |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04049584000019 [Primary] |
MXK | Device,Analysis,Anterior Segment |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-01 |
04049584005878 - Lorgnette with striated lenses (Bagolini), Axes 45°/123° | 2023-06-26 |
04049584032454 - Lidstick | 2023-06-26 |
04049584033048 - GONIO ready® 200 for f=200 | 2023-04-04 GONIO ready® 200 for f=200 |
04049584034489 - GONIO ready® 175 for f=175 | 2023-04-04 GONIO ready® 175 for f=175 |
04049584001030 - BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria | 2022-12-15 BK X/O (according to Kochniss), without convex cylinders, coated, inclusive trial lens case |
04049584001078 - Prism Lens Case, coated | 2022-12-15 Prism Lens Case, coated |
04049584001153 - Prism Lens Case S, coated | 2022-12-15 Prism Lens Case S, coated |
04049584001191 - BK 1/T, table version, trial lens case | 2022-12-15 BK 1/T, table version, trial lens case |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PENTACAM 79016552 3223229 Live/Registered |
Oculus Optikgeräte GmbH 2005-08-18 |
PENTACAM 74553281 1904295 Dead/Cancelled |
FOCAL POINT, INC., THE 1994-07-25 |