C-VIEW
- Primary DI
- 04048551313367
- Brand
- C-VIEW
- Company
- Karl Storz GmbH & Co. KG
- Model
- 11272VU
- Device description
- CMOS Video Cysto-Urethroscope
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| FBO | CYSTOURETHROSCOPE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FBO | Cystourethroscope | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551313367 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551313367 | 04048551313367 | 4048551313367 |
GMDN Terms
| Term | Definition |
|---|---|
| Flexible video cystoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide;Hydrogen Peroxide;Liquid Chemical |
Regulatory Flags
- DUNS number
- 315731430
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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