Rovers® Cervex-Brush®

GUDID 08719189246506

Cervical cell sampler

Rovers Medical Devices B.V.

Cytology scraper, single-use

• Primary Device ID: 08719189246506
• NIH Device Record Key: 916d9591-dc86-492f-ad06-2fdd123d1292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers® Cervex-Brush®
• Version Model Number: 70671-001
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719189246049 [Unit of Use]
GS1	08719189246506 [Primary]
GS1	18719189246503 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	28719189246500 [Package]; Contains: 18719189246503; Package: Export Box [176 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

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