Rovers® Viba-Brush®

GUDID 28719189246227

The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material from the vagina.

Rovers Medical Devices B.V.

Cytology scraper, single-use

• Primary Device ID: 28719189246227
• NIH Device Record Key: b846ddef-581f-4518-a028-d34464ba9eeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Viba-Brush®
• Version Model Number: 380200331
• Company DUNS: 402155084
• Company Name: Rovers Medical Devices B.V.
• Device Count: 100
• 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	08719189246223 [Unit of Use]
GS1	08719189246582 [Package]; Contains: 18719189246220; Package: [6 Units]; In Commercial Distribution
GS1	18719189246220 [Primary]
GS1	28719189246227 [Package]; Contains: 18719189246220; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933870

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® Viba-Brush®]

• 28719189246258: The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effec
• 28719189246227: The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effec
• 08719189246575: The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effec