FDA UDI
In Commercial Distribution
🇺🇸 United States
EleVision™
DI: 04250480110287
·
Model: ELEV4KCCU
·
SCHÖLLY FIBEROPTIC GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EleVision™
- Primary DI
- 04250480110287
- Version / Model
- ELEV4KCCU
- Company Name
- SCHÖLLY FIBEROPTIC GmbH
- Labeler DUNS
- 316276682
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 1
- Public Version Date
- 2021-06-04
- Public Version Status
- New
- Public Device Record Key
- 6ce28463-0004-404b-bde2-4ab838034dc3
Device Description
EleVision TM 4K Camera Control Unit
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
- 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 |
|---|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35958 | Endoscope video camera | An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250480110287 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal