Medscand Sample Collection Kit

GUDID 20888937022388

Medscand Sample Collection Kit

Coopersurgical, Inc.

Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical

• Primary Device ID: 20888937022388
• NIH Device Record Key: 63733b55-b2a6-480d-9dc9-50e21bdf4a8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medscand Sample Collection Kit
• Version Model Number: 70124-001
• 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: true
• 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	00888937022384 [Primary]
GS1	20888937022388 [Package]; Contains: 00888937022384; Package: Box [20 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-22
• Device Publish Date: 2023-02-14

Devices Manufactured by Coopersurgical, Inc.

• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023824 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023831 - K-Systems: 2024-02-27 L126 IVF, RI Witness Right