FDA UDI
In Commercial Distribution
🇺🇸 United States
CYSTO-NEPHRO VIDEOSCOPE
DI: 04953170411298
·
Model: OLYMPUS CYF-VHR
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CYSTO-NEPHRO VIDEOSCOPE
- Primary DI
- 04953170411298
- Version / Model
- OLYMPUS CYF-VHR
- Catalog Number
- N6006240
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-29
- Public Version
- 4
- Public Version Date
- 2023-02-07
- Public Version Status
- Update
- Public Device Record Key
- 8aed5a2c-3d3b-42f1-a64e-e8928035e40c
Device Description
CYSTO-NEPHRO VIDEOSCOPE
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
- ["High-level Disinfectant", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46723 | Flexible video cystonephroscope | An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. It is inserted into the urethra via the natural urinary orifice, or percutaneously into the renal pelvis for the kidneys during endoscopy. 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 the removal/crushing of stones; investigation of pyelitis and renal failure; treatment of lesions of the urinary bladder/posterior urethra; or to evaluate bladder control/incontinence. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170411298 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]