Primary Device ID | 06909071671055 |
NIH Device Record Key | 5c0a66ea-38bb-48de-9ff2-9c49b57d4196 |
Commercial Distribution Discontinuation | 2018-10-24 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | MARCO |
Version Model Number | MARCO ENCORE AUTOMATIC CHAIR |
Company DUNS | 690907167 |
Company Name | TAKAGI SEIKO CO.,LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06909071671055 [Primary] |
HME | Chair, Ophthalmic, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-10-24 |
Device Publish Date | 2016-09-09 |
06909071678474 | MARCO ULTRAM3 |
06909071678467 | MARCO ULTRA M4 |
06909071678450 | MARCO ULTRA MAX2 |
06909071678443 | MARCO ULTRA MAX5 |
06909071678436 | MARCO ULTRA M2 |
06909071678429 | MARCO ULTRA M5 |
06909071671222 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671215 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671192 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671185 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671178 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671161 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
06909071671147 | MARCO DELUXE2 STAND |
06909071671130 | MARCO NON CONSOLE DELUXE2 STAND |
06909071671109 | MARCO TRIAL LENS FRAME |
06909071671086 | MARCO BRAVO CHAIR |
06909071671079 | MARCO TILT CHAIR |
06909071671055 | MARCO ENCORE AUTOMATIC CHAIR |
06909071671048 | MARCO ENCORE MANUAL CHAIR |
04560323649127 | MARCO DELUXE 2 STAND |
04560323649110 | MARCO NON-CONSOLE DELUXE 2 STAND |
04560323649103 | MARCO ENCORE STAND |
04560323649035 | MARCO BRAVO CHAIR |
04560323649028 | MARCO TILT CHAIR |
04560323649011 | MARCO ENCORE AUTOMATIC CHAIR |
04560323649004 | MARCO ENCORE MANUAL CHAIR |
04560323648908 | MARCO TRIAL LENS FRAME |
04560323648601 | MARCO SURGISCOPE 3 |
04560323648526 | MARCO AT-8 APPLANATION TONOMETER |
04560323648502 | MARCO AT-9 APPLANATION TONOMETER |
04560323648472 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
04560323648465 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
04560323648434 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
04560323648427 | An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the |
04560323648137 | MARCO ORION OPHTHALMIC WORKSTATION |
04560323649158 | MARCO BRAVO STAND |
04560323649165 | MARCO DELUXE STAND |
04560323640940 | MARCO ULTRA M2 BI |