Rovers® Cervex-Brush® Combi

GUDID 08719189246476

Rovers Medical Devices B.V.

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• Primary Device ID: 08719189246476
• NIH Device Record Key: 2983a4bd-acd6-46fc-b814-3272b204d2e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Cervex-Brush® Combi
• Version Model Number: 380301031
• 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	08719189246476 [Package]; Contains: 18719189246602; Package: [6 Units]; In Commercial Distribution
GS1	08719189246605 [Unit of Use]
GS1	18719189246602 [Primary]
GS1	28719189246609 [Package]; Contains: 18719189246602; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043369

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® Cervex-Brush® Combi]

• 87191892461556: Cervical cell sampler, sterile
• 87191892460870: Cervical cell sampler
• 08719189246384: Cervical cell sampler
• 08719189246155: Cervical cell sampler, sterile
• 08719189246070: Cervical cell sampler
• 08719189246476: 380301031
• 28719189246081: The Cervex-Brush® Combi is a single-use cell sampler intended to collect simultaneous cell mate