FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Genesys HTA ProCerva
DI: 08714729809456
·
Model: M006580210
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Genesys HTA ProCerva
- Primary DI
- 08714729809456
- Version / Model
- M006580210
- Catalog Number
- M006580210
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2021-05-20
- Public Version Status
- Update
- Public Device Record Key
- f421e10a-af6d-41cc-b1a0-059b67efd4dd
- Distribution End Date
- 2021-01-19
Device Description
Procedure Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40784 | Extravascular-circulation hyperthermia system | An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. It is typically a computer-controlled configuration used for curative or palliative treatment by causing the temperature of the whole body, localized areas, or targeted organs to rise to temperatures greater than 43? Celsius. It is typically used in an oncology department. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729809463 | GS1 | 5 | Not in Commercial Distribution | 2021-01-19 | |
| Primary | 08714729809456 | GS1 |