FDA UDI
In Commercial Distribution
🇺🇸 United States
Saneso
DI: G347SBA0
·
Model: G347SBA
·
Saneso Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Saneso
- Primary DI
- G347SBA0
- Version / Model
- G347SBA
- Company Name
- Saneso Inc.
- Labeler DUNS
- 117059270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-11
- Public Version
- 1
- Public Version Date
- 2022-11-21
- Public Version Status
- New
- Public Device Record Key
- c4dfd693-51f9-45eb-ba3b-1d5c31869640
Device Description
The Saneso Box incorporates state of the art electronics and software and is the brain behind Saneso’s endoscopy system. It executes all technological innovations incorporated in the Saneso colonoscope and gastroscope.
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 |
|---|---|---|---|---|
| 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 | G347SBA0 | HIBCC |
Customer Contacts
- Phone
- 6812984613
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210052 | 000 |