OCT Ophthalmoscope A10700

GUDID 05057056107004

The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of poster

OPTOS PUBLIC LIMITED COMPANY

Retinal optical coherence tomography system
Primary Device ID05057056107004
NIH Device Record Key1ae8c9de-f4c7-444b-9ba6-61365832f161
Commercial Distribution StatusIn Commercial Distribution
Brand NameOCT Ophthalmoscope
Version Model NumberP200TE
Catalog NumberA10700
Company DUNS346013337
Company NameOPTOS PUBLIC LIMITED COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com
Phone+4401383843351
EmailGMcleod@optos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105057056107004 [Primary]

FDA Product Code

MYCOphthalmoscope,Laser,Scanning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-03
Device Publish Date2018-04-02

On-Brand Devices [OCT Ophthalmoscope]

05057056107004The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer inte
05057056107509A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy

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