EVA System

GUDID 17290016976547

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 ID17290016976547
NIH Device Record Keyacc396db-c18e-4b4b-a790-c00e0e2a4b66
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA System
Version Model NumberEVA 3 Plus/EVA 3.1
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
GS117290016976028 [Primary]
GS117290016976509 [Package]
Contains: 17290016976028
Package: US [1 Units]
In Commercial Distribution
GS117290016976516 [Package]
Contains: 17290016976028
Package: EU [1 Units]
In Commercial Distribution
GS117290016976523 [Package]
Contains: 17290016976028
Package: UK [1 Units]
In Commercial Distribution
GS117290016976547 [Package]
Contains: 17290016976028
Package: Universal [1 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-21
Device Publish Date2018-11-20

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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