ATLAS Corneal Topography System

GUDID 04057748081118

The ZEISS ATLAS Corneal Topography System is intended to measure and analyze the corneal curvature of the eye.

Carl Zeiss Meditec, Inc.

Corneal topography system
Primary Device ID04057748081118
NIH Device Record Keyf63ad62f-68b5-4002-b5a4-1cf3055ff848
Commercial Distribution Discontinuation2018-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameATLAS Corneal Topography System
Version Model Number9000
Company DUNS362747011
Company NameCarl Zeiss Meditec, Inc.
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104057748081118 [Primary]

FDA Product Code

HJBInstrument, Measuring, Corneal Radius

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-16
Device Publish Date2018-06-13

Devices Manufactured by Carl Zeiss Meditec, Inc.

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