FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GYNECARE THERMACHOICE
DI: 10705031000865
·
Model: 00825
·
ETHICON INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GYNECARE THERMACHOICE
- Primary DI
- 10705031000865
- Version / Model
- 00825
- Catalog Number
- 00825
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c100c859-61b4-4037-8003-947423511960
- Distribution End Date
- 2018-02-01
Device Description
Uterine Balloon Therapy System
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705031000865 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius