FDA UDI
In Commercial Distribution
🇺🇸 United States
ZEOS
DI: 00812231034033
·
Model: 84-10-4101
·
SANTA BARBARA IMAGING SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ZEOS
- Primary DI
- 00812231034033
- Version / Model
- 84-10-4101
- 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
- 2023-12-08
- Public Version
- 1
- Public Version Date
- 2023-12-18
- Public Version Status
- New
- Public Device Record Key
- 9e7379f7-df86-440d-954c-b12f98a62e86
Device Description
ZEOS CAMERA HEAD, GUILLOTINE, 4K, 3CMOS
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 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 | 00812231034033 | GS1 | ||||
| Package | 00812231034057 | GS1 | Loaner | 1 | In Commercial Distribution | |
| Package | 00812231034040 | GS1 | Repair-Replace | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 805-770-2110
- [email protected]