FDA UDI
In Commercial Distribution
🇺🇸 United States
USB K-switch
DI: 08055060110178
·
Model: Accessory to GI Genius
·
LINKVERSE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- USB K-switch
- Primary DI
- 08055060110178
- Version / Model
- Accessory to GI Genius
- Catalog Number
- UKS01
- Company Name
- LINKVERSE SRL
- Labeler DUNS
- 338806666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 1
- Public Version Date
- 2023-08-21
- Public Version Status
- New
- Public Device Record Key
- f785e0ff-b446-44dc-86ff-1cc72613e3bc
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | Gastroenterology, Urology | 876.1520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055060110178 | GS1 |
Customer Contacts
- Phone
- +390690287198
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231143 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 75.3 – 101.3 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 75.3 – 101.3 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity