Medscand® Sample Collection Kit

GUDID 20888937010958

Medscand® Sample Collection Kit for use with The ThinPrep® Pap Test™ Cytobrush® Plus GT • Pap-Perfect® Plastic Spatula

Coopersurgical, Inc.

Papanicolaou smear kit

• Primary Device ID: 20888937010958
• NIH Device Record Key: 134ed6e4-a7ab-4eed-ab79-16ce25105692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medscand® Sample Collection Kit
• Version Model Number: 02500
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937010958 [Package]; Contains: 60888937010956; Package: [20 Units]; In Commercial Distribution
GS1	60888937010956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861389

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: 2017-10-10

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