Mara

GUDID 00888937026887

Mara Water Vapor Probe Kit

Coopersurgical, Inc.

Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator Water vapour endometrial-ablation applicator

• Primary Device ID: 00888937026887
• NIH Device Record Key: a9c47fbf-1952-4f84-9f98-09c40ddee402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mara
• Version Model Number: DDK-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: 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	00857379006030 [Previous]
GS1	00888937026887 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

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• 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