Rovers® Cervex-Brush® Combi RT

GUDID 87191892461938

Cervical cell sampler

Rovers Medical Devices B.V.

Cytology scraper, single-use Cytology scraper, single-use

• Primary Device ID: 87191892461938
• NIH Device Record Key: 8e6ef900-5601-4f2e-aeb0-2f75959a2d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Cervex-Brush® Combi RT
• Version Model Number: 380301000
• Company DUNS: 402155084
• Company Name: Rovers Medical Devices B.V.
• Device Count: 25
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31412648870
• Email: info@roversmedicaldevices.com
• Phone: +31412648870
• Email: info@roversmedicaldevices.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719189246209 [Unit of Use]
GS1	87191892461860 [Primary]
GS1	87191892461938 [Package]; Contains: 87191892461860; Package: Box [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-17
• Device Publish Date: 2016-12-07

On-Brand Devices [Rovers® Cervex-Brush® Combi RT]

• 87191892461938: Cervical cell sampler
• 08719189246186: Cervical cell sampler