GYNECARE THERMACHOICE 01105

GUDID H206011051

Thermal Balloon Ablation Umbilical Cable. For use only with GYNECARE THERMACHOICE TM UBT System Controller.

ETHICON INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: H206011051
• NIH Device Record Key: 970cf7bc-2bdc-430b-8089-f49346700b05
• Commercial Distribution Discontinuation: 2018-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GYNECARE THERMACHOICE
• Version Model Number: 01105
• Catalog Number: 01105
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031000886 [Primary]
HIBCC	H206011051 [Secondary]

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: 2
• Public Version Date: 2018-03-29
• 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