FDA UDI
In Commercial Distribution
🇺🇸 United States
TECNIMED
DI: 00182097000368
·
Model: Disc-o-Click
·
TECNIMED SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TECNIMED
- Primary DI
- 00182097000368
- Version / Model
- Disc-o-Click
- Company Name
- TECNIMED SRL
- Labeler DUNS
- 445878788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 4
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- eaf07fc9-8112-4c05-87f0-1f617ea52f3c
Device Description
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | Neurology | 882.5894 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59437 | Insect bite/sting electrical stimulator | A portable device intended to be used for the external treatment of insect bites or stings (e.g., from mosquitoes) through dispatch of a small (e.g., 13 kV) piezeoelectric charge to the affected region of the skin. The charge is intended to localize the poison and inhibit histamine release therefore reducing itching and inflammation. It typically consists of a pocket-sized, hand-held housing containing piezocrystal with a trigger mechanism. It is available [non-prescription] over-the-counter (OTC) for home-use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00182097000382 | GS1 | carton box | 3 | In Commercial Distribution | |
| Primary | 00182097000368 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar