Rovers® EndoCervex-Brush®-S

GUDID 28719189246296

The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.

Rovers Medical Devices B.V.

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• Primary Device ID: 28719189246296
• NIH Device Record Key: eb2e76e8-9fe5-41a6-81f0-243562069ef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® EndoCervex-Brush®-S
• Version Model Number: 380100745
• 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	08719189246292 [Unit of Use]
GS1	08719189246520 [Package]; Contains: 18719189246299; Package: [6 Units]; In Commercial Distribution
GS1	18719189246299 [Primary]
GS1	28719189246296 [Package]; Contains: 18719189246299; 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

Devices Manufactured by Rovers Medical Devices B.V.

• 08719189246445 - Rovers® Evalyn® Brush: 2023-07-20 The Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe and effective collection of cell
• 08719189246544 - Rovers® Anex® Brush: 2023-07-20 The Anex® Brush is a single-use cell sampler intended to collect cells from the anal canal.
• 28719189246081 - Rovers® Cervex-Brush® Combi: 2023-07-20 The Cervex-Brush® Combi is a single-use cell sampler intended to collect simultaneous cell material from the ectocervical, endo
• 08719189246575 - Rovers® Viba-Brush®: 2023-07-20 The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material
• 28719189246227 - Rovers® Viba-Brush®: 2023-07-20 The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material
• 28719189246258 - Rovers® Viba-Brush®: 2023-07-20 The Viba-Brush® is a single use cell-sampling device that allows easy, painless, safe and effective collection of cell material
• 08719189246261 - Rovers® Cervex-Brush®: 2023-07-20 The Cervex-Brush® is a single-use cell sampler intended to collect simultaneous cell material from the cervical os, ectocervica
• 08719189246551 - Rovers® EndoCervex-Brush®: 2023-07-20 The EndoCervex-Brush® is a single-use cell sampler intended to collect endocervical cells.