Rovers® EndoCervex-Brush®

GUDID 08719189246551

The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.

Rovers Medical Devices B.V.

Cytology scraper, single-use

• Primary Device ID: 08719189246551
• NIH Device Record Key: d661ec57-4df4-4796-aee6-7172e4a7c5cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® EndoCervex-Brush®
• Version Model Number: 380300731
• 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	08719189246278 [Unit of Use]
GS1	08719189246551 [Package]; Contains: 18719189246275; Package: [6 Units]; In Commercial Distribution
GS1	18719189246275 [Primary]
GS1	28719189246272 [Package]; Contains: 18719189246275; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001119

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® EndoCervex-Brush®]

• 87191892461174: EndoCervical cell sampler
• 08719189246513: The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.
• 08719189246551: The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.