Papette

GUDID 20888937011290

WALLACH Papette® (Non-Sterile) Cervical Cell Sampler

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 20888937011290
• NIH Device Record Key: b95de841-aea1-49e4-a085-fdb3b309b16c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Papette
• Version Model Number: 908003
• 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: false
• 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	20888937011290 [Package]; Contains: 50888937011291; Package: [1000 Units]; In Commercial Distribution
GS1	50888937011291 [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: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-09-21

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