FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GYNECARE THERMACHOICE
DI: 20705031050744
·
Model: TC013
·
ETHICON INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GYNECARE THERMACHOICE
- Primary DI
- 20705031050744
- Version / Model
- TC013
- Catalog Number
- TC013
- Company Name
- ETHICON INC.
- Labeler DUNS
- 002144145
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 3
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 7c43cbc5-98e5-4b6d-90cd-fa8fdbba0d3a
- Distribution End Date
- 2018-02-02
Device Description
Uterine Balloon Therapy System with Fluid Circulation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H206TC0131 | HIBCC | ||||
| Primary | 20705031050744 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry cool place
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Resterilize