GYNECARE THERMACHOICE TC013

GUDID H206TC0131

Circulating-fluid endometrial-ablation catheter Circulating-fluid endometrial-ablation catheter

Primary Device ID	H206TC0131
NIH Device Record Key	7c43cbc5-98e5-4b6d-90cd-fa8fdbba0d3a
Commercial Distribution Discontinuation	2018-02-02
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	GYNECARE THERMACHOICE
Version Model Number	TC013
Catalog Number	TC013
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	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

Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize
Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize
Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize
Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize
Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize
Special Storage Condition, Specify	Between 0 and 0 *Do Not Resterilize

Device Issuing Agency	Device ID
GS1	20705031050744 [Primary]
HIBCC	H206TC0131 [Secondary]

MNB	DEVICE, THERMAL ABLATION, ENDOMETRIAL

Steralize Prior To Use	false
Device Is Sterile	true

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