Rovers ® Combo-brush® 490526

GUDID 10382904905269

Rovers ® Cervex-Brush® Combi

TRIPATH IMAGING, INC.

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• Primary Device ID: 10382904905269
• NIH Device Record Key: 0278b9ec-ab5f-45ef-9484-be47dca49f8c
• Commercial Distribution Discontinuation: 2021-10-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rovers ® Combo-brush®
• Version Model Number: 490526
• Catalog Number: 490526
• Company DUNS: 103318015
• Company Name: TRIPATH IMAGING, INC.
• 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: false
• 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: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_Services@bd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904905262 [Unit of Use]
GS1	10382904905269 [Primary]
GS1	30382904905263 [Package]; Package: Shelf Pack [20 Units]; Discontinued: 2021-10-01; 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: 2019-04-05
• Device Publish Date: 2016-09-24

Devices Manufactured by TRIPATH IMAGING, INC.

• 10382904905245 - ROVERS® CERVEX-BRUSH®: 2019-04-05 ROVERS® CERVEX-BRUSH®
• 10382904905269 - Rovers ® Combo-brush®: 2019-04-05Rovers ® Cervex-Brush® Combi
• 10382904905269 - Rovers ® Combo-brush®: 2019-04-05 Rovers ® Cervex-Brush® Combi
• 10382904912533 - BD SurePath™ Collection Vial Kit 500: 2019-04-05 BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)
• 30382904913244 - BD SurePath™ Collection Vial Kit 25: 2019-04-05 BD SurePath™ Collection Vial Kit 25
• 30382904913299 - BD Settling Chambers: 2019-04-05 BD Settling Chambers (96). Consumables for use on the PrepStain instrument.
• 30382904913305 - BD Settling Chambers: 2019-04-05 BD Settling Chambers
• 00382904912475 - BD SurePath: 2019-04-05 BD SurePath™ GYN Cytology Test Kit
• 00382904913069 - BD Density Reagent: 2019-04-05 BD Density Reagent (1900mL)