FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOCAM
DI: 04055207063286
·
Model: 5525301
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOCAM
- Primary DI
- 04055207063286
- Version / Model
- 5525301
- Catalog Number
- 5525301
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-09
- Public Version
- 5
- Public Version Date
- 2021-04-23
- Public Version Status
- Update
- Public Device Record Key
- f4301134-8a4b-4b99-ad14-ecdb0fd65c50
Device Description
LOGIC 4K CAMERA CONTROLLER touch screen, color display, compatible with core nova, Input: 1x 3G-SDI (PiP), Output: 2x HDMI 4K, 2x HDMI HD, 2x 3G-SDI, Capturing video/images on USB, Resolution: 3840x2160, 1920x1200, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x120x416mm
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 |
|---|---|---|---|---|
| FET | Endoscopic video imaging system/component, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 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 | 04055207063286 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]