Pap Perfect

GUDID 20888937003165

Plastic cervical scrapers

Coopersurgical, Inc.

Papanicolaou smear kit

• Primary Device ID: 20888937003165
• NIH Device Record Key: 43e6cc04-4689-41bf-a428-04c1ac60f1c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pap Perfect
• Version Model Number: 11080
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937003165 [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: 2016-09-21

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• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
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• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right