Galileo Colposcope, Direct Access

GUDID GYNX200LDAR0

GYNEX CORPORATION

Colposcope

• Primary Device ID: GYNX200LDAR0
• NIH Device Record Key: 4da50ffa-a535-4dc2-98fc-823c0177e831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galileo Colposcope, Direct Access
• Version Model Number: 200LDA-R
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNX200LDAR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061306

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-05

On-Brand Devices [Galileo Colposcope, Direct Access]

• GYNX430VCDAT0: 430VCDA-T
• GYNX430VCDAR0: 430VCDA-R
• GYNX430LVCDAT0: 430LVCDA-T
• GYNX430LVCDAR0: 430LVCDA-R
• GYNX400LDAT0: 400LDA-T
• GYNX400DAT0: 400DA-T
• GYNX400DAR0: 400DA-R
• GYNX200LDAT0: 200LDA-T
• GYNX200LDAR0: 200LDA-R
• GYNX200DAT0: 200DA-T
• GYNX200DAR0: 200DA-R