Cervex-Brush

GUDID 20888937014390

Cervex-Brush® Cervical Cell Sampler For simultaneous cytologic sampling of both the uterine ectocervix and endocervix for such subsequent evaluations

Coopersurgical, Inc.

Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush

• Primary Device ID: 20888937014390
• NIH Device Record Key: adc5e921-40a5-4f77-b6b2-77e755544868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervex-Brush
• Version Model Number: 8600
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937014390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890848

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

Devices Manufactured by Coopersurgical, Inc.

• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023824 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023831 - K-Systems: 2024-02-27 L126 IVF, RI Witness Right