AccessGUDID - DEVICE: GYNECARE THERMACHOICE (10705031000865)

GUDID

Device Identifier (DI) Information

Brand Name: GYNECARE THERMACHOICE
Version or Model: 00825
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00825
Company Name: ETHICON INC.

Primary DI Number: 10705031000865
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: Uterine Balloon Therapy System

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:	No
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?
35030	Electrocautery system generator, line-powered	A mains electricity (AC-powered) device that regulates an electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c100c859-61b4-4037-8003-947423511960
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2014