Cytobrush Plus GT

GUDID 30888937003216

Gentle touch tip 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 Cervical cytology brush

• Primary Device ID: 30888937003216
• NIH Device Record Key: e95fd96a-b9c9-4b58-bfae-80849213e5ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytobrush Plus GT
• Version Model Number: C0105
• 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	20888937003219 [Package]; Contains: 50888937003210; Package: Box [2500 Units]; In Commercial Distribution
GS1	30888937003216 [Package]; Contains: 20888937003219; Package: Case [4 Units]; In Commercial Distribution
GS1	50888937003210 [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 GT]

• 30888937003223: Gentle touch tip cell collector
• 30888937003216: Gentle touch tip cell collector
• 30888937003209: Gentle Touch Tip Cell Collector
• 30888937003285: Gentle touch tip cell collector