Her Option

GUDID 00888937000016

Her Option Console

Coopersurgical, Inc.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 00888937000016
• NIH Device Record Key: fe5269a1-7062-4594-8ee5-e79142536cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Her Option
• Version Model Number: CG-1
• 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: 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	00888937000016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000032

FDA Product Code

• MNB: Device, Thermal Ablation, Endometrial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-19
• Device Publish Date: 2014-09-17

On-Brand Devices [Her Option ]

• 20888937000027: Her Option Disposable Probe
• 00888937000016: Her Option Console