FDA UDI
In Commercial Distribution
🇺🇸 United States
NovaSure SureSound
DI: 15420045501126
·
Model: 2013
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- NovaSure SureSound
- Primary DI
- 15420045501126
- Version / Model
- 2013
- Catalog Number
- NS2013KITUS
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9a66b689-26e8-4f06-9685-7a4a27b18f31
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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
- 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 |
|---|---|---|---|---|
| 40794 | Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal | A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045501126 | GS1 | ||||
| Package | 35420045501120 | GS1 | CARTON | 3 | In Commercial Distribution | |
| Package | 25420045501123 | GS1 | BOX | 1 | In Commercial Distribution | |
| Package | 45420045501127 | GS1 | BOX | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010013 | 055 |