FDA UDI
In Commercial Distribution
🇺🇸 United States
EvoEndo Controller
DI: 00850031897021
·
Model: EE-C
·
Evoendo, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EvoEndo Controller
- Primary DI
- 00850031897021
- Version / Model
- EE-C
- Catalog Number
- 1002
- Company Name
- Evoendo, Inc.
- Labeler DUNS
- 117077970
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-25
- Public Version
- 1
- Public Version Date
- 2022-03-07
- Public Version Status
- New
- Public Device Record Key
- e7f95954-b645-4f6c-9ac4-aa371d926af8
Device Description
The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable
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
- 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 |
|---|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47140 | Endoscopic control/video-imaging system | A mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850031897021 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213606 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 109 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius