Rovers® Evalyn® Brush

GUDID 08719189246445

The Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe and effective collection of cell material from the vagina.

Rovers Medical Devices B.V.

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• Primary Device ID: 08719189246445
• NIH Device Record Key: c48a308d-41cb-4e71-a3c8-8abaca4f2fd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Evalyn® Brush
• Version Model Number: 380500150
• Company DUNS: 402155084
• Company Name: Rovers Medical Devices B.V.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	08719189246445 [Primary]

FDA Product Code

• HHT: Spatula, Cervical, Cytological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [Rovers® Evalyn® Brush]

• 18719189246435: Vaginal cell sampler, sterile
• 08719189246445: The Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe a