EVA System

GUDID 17290016976011

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 ID: 17290016976011
• NIH Device Record Key: d96a4d36-d618-4fc7-a753-982e46b58f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA System
• Version Model Number: 3.0
• Company DUNS: 600049276
• Company Name: MOBILEODT LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290016976011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161871

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [EVA System]

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