FDA UDI
In Commercial Distribution
🇺🇸 United States
Solero
DI: H787700106001US0
·
Model: 700106001-US
·
ANGIODYNAMICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Solero
- Primary DI
- H787700106001US0
- Version / Model
- 700106001-US
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-10
- Public Version
- 5
- Public Version Date
- 2021-10-26
- Public Version Status
- Update
- Public Device Record Key
- e6ab65fb-72eb-427f-a88a-bcd144deaf04
Device Description
Microwave Tissue Ablation Applicator
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40792 | Microwave hyperthermia system applicator, intracorporeal | A component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device 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 | H787700106001US0 | HIBCC | ||||
| Secondary | 15051684017848 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162449 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Centimeter |