FDA UDI
In Commercial Distribution
🇺🇸 United States
HS AMICA
DI: 08058983742211
·
Model: RF AMICA-PROBE
·
H.S. HOSPITAL SERVICE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HS AMICA
- Primary DI
- 08058983742211
- Version / Model
- RF AMICA-PROBE
- Catalog Number
- RF18070E15V2-T
- Company Name
- H.S. HOSPITAL SERVICE SPA
- Labeler DUNS
- 428898555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 1
- Public Version Date
- 2021-02-08
- Public Version Status
- New
- Public Device Record Key
- 1e6edda9-c8c7-486a-a917-41f9c70753c0
Device Description
RF AMICA-PROBE 18GX70MM EXP. TIP 15MM
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
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
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 | 08058983742211 | GS1 |
Customer Contacts
- Phone
- +39069201961
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150112 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge | |
| Length | 70 | Millimeter |