n.a.
- Primary DI
- 04048551226186
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 11272VN
- Device description
- Flexible Video Urethro-Cystoscope
- 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 |
|---|---|---|---|---|
| 04048551226186 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551226186 | 04048551226186 | 4048551226186 |
GMDN Terms
| Term | Definition |
|---|---|
| Flexible video cystourethroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is used for biopsy, removal of small stones, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid |
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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