Papette

GUDID 20888937011313

WALLACH Papette® (Non-Sterile) Cervical Cell Sampler

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: 20888937011313
• NIH Device Record Key: f73b1f56-3f62-4d38-9aa3-7d68330cca05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Papette
• Version Model Number: 908003-2
• 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	20888937011313 [Package]; Contains: 50888937011314; Package: [10 Units]; In Commercial Distribution
GS1	50888937011314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896065

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: 2016-09-23

On-Brand Devices [Papette]

• 20888937011320: WALLACH Papette® (Non-Sterile) Cervical Cell Sampler
• 20888937011313: WALLACH Papette® (Non-Sterile) Cervical Cell Sampler
• 20888937011306: WALLACH Papette® (Non-sterile) Cervical Cell Sampler
• 20888937011290: WALLACH Papette® (Non-Sterile) Cervical Cell Sampler
• 50888937011284: WALLACH Papette
• 50888937011277: WALLACH Papette® (Non-Sterile) For Cervical Cytology utilizing the Conventional Pap Smear