EVA System

GUDID 17290016976004

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in d

MOBILEODT LTD

Colposcope
Primary Device ID17290016976004
NIH Device Record Keye7324ef7-cef0-4f94-8e0a-8c004b4986be
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA System
Version Model Number2
Company DUNS600049276
Company NameMOBILEODT LTD
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290016976004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEXColposcope (And Colpomicroscope)

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 Date2017-05-16

On-Brand Devices [EVA System]

17290016976547The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagi
17290016976011The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagi
17290016976004The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagi

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