Mara Console

GUDID 00888937026870

Mara Console- Endometrial Ablation

Coopersurgical, Inc.

Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit

• Primary Device ID: 00888937026870
• NIH Device Record Key: bbf8bd79-0dd9-4c5a-9112-3f73dde93e8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mara Console
• Version Model Number: GEN-16-050
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00888937026870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160047

FDA Product Code

• MNB: Device, Thermal Ablation, Endometrial

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: 2024-03-21
• Device Publish Date: 2024-03-13

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: 2024-03-21Mara Console- Endometrial Ablation
• 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