FDA UDI
In Commercial Distribution
🇺🇸 United States
815012US
DI: 25420045505398
·
Model: 815012US
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- 815012US
- Primary DI
- 25420045505398
- Version / Model
- 815012US
- Catalog Number
- 815012US
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 4
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 4dcca622-4c17-45e0-8cfc-0d02ff2d8fb2
Device Description
The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 66633 | Radio-frequency endometrial-ablation system generator | An electrically-powered device intended to produce radio-frequency (RF) energy at a predetermined power (based on uterus size) for coagulation/ablation of the endometrium with a handpiece/electrode (not included) to treat menorrhagia. The RF generator is also intended to facilitate carbon dioxide (CO2) delivery from a CO2 cartridge for assessment of uterine cavity integrity (intactness), and includes a suction pump intended to facilitate constant contact between the electrode and endometrium. It is intended to monitor tissue impedance [resistance of the tissue to alternating electrical current (AC)] to automatically interrupt ablation at a pre-set impedance threshold. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 25420045505398 | GS1 | ||||
| Unit of Use | 15420045505391 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010013 | 000 |