Rovers® Cervex-Brush®

GUDID 28719189246395

The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervical and endo cervical canal in women.

Rovers Medical Devices B.V.

Cytology scraper, single-use

• Primary Device ID: 28719189246395
• NIH Device Record Key: 2bd720bd-4072-41f3-b719-05ad0060137f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Cervex-Brush®
• Version Model Number: 380300331
• 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	08719189246391 [Unit of Use]
GS1	08719189246421 [Package]; Contains: 18719189246398; Package: [6 Units]; In Commercial Distribution
GS1	18719189246398 [Primary]
GS1	28719189246395 [Package]; Contains: 18719189246398; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930955

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®]

• 87191892460566: Cervical cell sampler, sterile
• 87191892460252: Cervical cell sampler
• 87191892460016: Cervical cell sampler
• 08719189246506: Cervical cell sampler
• 08719189246056: Cervical cell sampler, sterile
• 87191892466018: Cervical cell sampler
• 28719189246395: The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material f
• 08719189246261: The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material f