Cytobrush Plus

GUDID 30888937003193

Cell collector

Coopersurgical, Inc.

Cervical cytology brush

• Primary Device ID: 30888937003193
• NIH Device Record Key: 0dceea16-e688-4b0d-b497-71c9fd0ad330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytobrush Plus
• Version Model Number: C0021
• 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: false
• 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	20888937003196 [Package]; Contains: 50888937003197; Package: Box [1000 Units]; In Commercial Distribution
GS1	30888937003193 [Package]; Contains: 20888937003196; Package: Case [10 Units]; In Commercial Distribution
GS1	50888937003197 [Primary]

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: 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: 2016-09-21

On-Brand Devices [Cytobrush Plus]

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