FDA UDI
In Commercial Distribution
🇺🇸 United States
ZEOS
DI: 00812231031896
·
Model: 84-10-2410
·
SANTA BARBARA IMAGING SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ZEOS
- Primary DI
- 00812231031896
- Version / Model
- 84-10-2410
- Catalog Number
- 84-10-2410
- Company Name
- SANTA BARBARA IMAGING SYSTEMS, INC.
- Labeler DUNS
- 065016344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-25
- Public Version
- 2
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- c3476e8f-2e1a-4dcd-b9fa-44ce31cace0f
Device Description
ZEOS HD CAMERA CONTROL UNIT, JPN
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 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 |
|---|---|---|---|---|---|---|
| Package | 00812231031995 | GS1 | Loaner | 1 | In Commercial Distribution | |
| Primary | 00812231031896 | GS1 |
Customer Contacts
- Phone
- 8057702110
- [email protected]