DEVICE: GYNECARE THERMACHOICE (10705031050730)

Download: XML | JSON

Device Identifier (DI) Information

GYNECARE THERMACHOICE
TC003
TC003
ETHICON INC.
10705031050730
GS1
1
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Circulating-fluid endometrial-ablation catheter A sterile 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNB DEVICE, THERMAL ABLATION, ENDOMETRIAL
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 20, 2014

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20705031050737 5 10705031050730 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE