GYNECARE THERMACHOICE 00825

GUDID 10705031000865

Uterine Balloon Therapy System

Ethicon Inc.

Electrocautery system generator, line-powered

• Primary Device ID: 10705031000865
• NIH Device Record Key: c100c859-61b4-4037-8003-947423511960
• Commercial Distribution Discontinuation: 2018-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GYNECARE THERMACHOICE
• Version Model Number: 00825
• Catalog Number: 00825
• Company DUNS: 002144145
• Company Name: Ethicon 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031000865 [Primary]

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: 3
• Public Version Date: 2025-07-17
• Device Publish Date: 2014-09-20

On-Brand Devices [GYNECARE THERMACHOICE]

• H206TC0131: Uterine Balloon Therapy System with Fluid Circulation
• H206011051: Thermal Balloon Ablation Umbilical Cable. For use only with GYNECARE THERMACHOICE TM UBT System
• 20705031050737: With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For u
• 10705031000865: Uterine Balloon Therapy System