FDA UDI
In Commercial Distribution
🇺🇸 United States
Saneso
DI: G347SAN360CA0
·
Model: SAN360C-A
·
Saneso Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Saneso
- Primary DI
- G347SAN360CA0
- Version / Model
- SAN360C-A
- Company Name
- Saneso Inc.
- Labeler DUNS
- 117059270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-04
- Public Version
- 1
- Public Version Date
- 2022-11-14
- Public Version Status
- New
- Public Device Record Key
- 633b968f-95e4-4ffa-80c7-a0a9f674a321
Device Description
Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen.
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 |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36117 | Flexible video colonoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G347SAN360CA0 | HIBCC |
Customer Contacts
- Phone
- 6812984613
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210052 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1680 | Millimeter | |
| Outer Diameter | 15.6 | Millimeter |