Gynius GYN-0001

GUDID 07300009046461

The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used

Gynius AB

Colposcope

• Primary Device ID: 07300009046461
• NIH Device Record Key: e9e4cc64-ccd7-4bdc-bf8b-1072b4f7752a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynius
• Version Model Number: V1
• Catalog Number: GYN-0001
• Company DUNS: 777393922
• Company Name: Gynius AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +468303035
• Email: info@gynocular.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07300009046461 [Primary]

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22