AccessGUDID - DEVICE: GYNECARE THERMACHOICE (20705031050744)

GUDID

Device Identifier (DI) Information

Brand Name: GYNECARE THERMACHOICE
Version or Model: TC013
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TC013
Company Name: ETHICON INC.

Primary DI Number: 20705031050744
Issuing Agency: GS1
Commercial Distribution End Date: February 02, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: Uterine Balloon Therapy System with Fluid Circulation

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58864	Circulating-fluid endometrial-ablation catheter	A device in the form of a thin tube with an inflatable balloon at its distal tip intended to be used to provide heat ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is designed to be attached to a hand-held control unit in which a fluid medium (e.g., glycerin) is heated before being forced into the catheter balloon under pressure to compress against the uterine wall and circulate within for homogenous heat distribution. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	DEVICE, THERMAL ABLATION, ENDOMETRIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry cool place
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Do Not Resterilize

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c43cbc5-98e5-4b6d-90cd-fa8fdbba0d3a
Public Version Date: April 20, 2020
Public Version Number: 3
DI Record Publish Date: September 20, 2014