FDA UDI
In Commercial Distribution
🇺🇸 United States
HS AMICA
DI: 08033055149273
·
Model: AMICA-GEN
·
H.S. HOSPITAL SERVICE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HS AMICA
- Primary DI
- 08033055149273
- Version / Model
- AMICA-GEN
- Catalog Number
- AGN-3.0
- 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
- 2019-12-19
- Public Version
- 1
- Public Version Date
- 2019-12-27
- Public Version Status
- New
- Public Device Record Key
- d455b9fd-1af8-49e7-b03d-16298074a7a9
Device Description
AMICA-GEN MW GENERATOR 140W
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 40783 | Microwave hyperthermia system | A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033055149273 | GS1 |
Customer Contacts
- Phone
- +39069201961
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150112 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 13 | Centimeter | |
| Width | 47 | Centimeter | |
| Depth | 35 | Centimeter | |
| Weight | 10.5 | Kilogram |