FDA UDI
In Commercial Distribution
🇺🇸 United States
4K UHD Camera System
DI: 06971381250060
·
Model: ES-CS4K100/100C
·
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 4K UHD Camera System
- Primary DI
- 06971381250060
- Version / Model
- ES-CS4K100/100C
- Company Name
- SCIVITA MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 544519831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-17
- Public Version
- 1
- Public Version Date
- 2023-05-25
- Public Version Status
- New
- Public Device Record Key
- d1367c3f-43ab-4810-9ac8-3c83b90af5b5
Device Description
The proposed system, 4K UHD Camera System, comprises the 4K camera control unit, 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18034 | Endoscopic video image processing unit | An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971381250060 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200216 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 28 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 55 Degrees Celsius