Cytobrush Plus

GUDID 30888937003278

Cell collector

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

• Primary Device ID: 30888937003278
• NIH Device Record Key: 64a3eadf-7599-4755-840f-6932ee2bee6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytobrush Plus
• Version Model Number: C0012
• 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	00888937003277 [Primary]
GS1	20888937003271 [Package]; Contains: 00888937003277; Package: [40 Units]; In Commercial Distribution
GS1	30888937003278 [Package]; Contains: 00888937003277; Package: [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832986

FDA Product Code

• HHT: Spatula, Cervical, Cytological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-25

On-Brand Devices [Cytobrush Plus]

• 30888937003193: Cell collector
• 30888937003186: Cell Collector
• 30888937003179: Cell Collector
• 30888937003278: Cell collector