FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OES CYSTONEPHROFIBERSCOPE
DI: 04953170292521
·
Model: OLYMPUS CYF-5A
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OES CYSTONEPHROFIBERSCOPE
- Primary DI
- 04953170292521
- Version / Model
- OLYMPUS CYF-5A
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-06
- Public Version
- 6
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- c380c7b6-3d73-48e3-b916-16d1d46b51dc
- Distribution End Date
- 2024-01-12
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
- Yes
- 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
- ["Ethylene Oxide", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGE | FORCEPS, BIOPSY, ELECTRIC | Gastroenterology, Urology | 876.4300 | 2 |
| FAJ | Cystoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FGA | Kit, nephroscope | Gastroenterology, Urology | 876.1500 | 2 |
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
| FCL | FORCEPS, BIOPSY, NON-ELECTRIC | Gastroenterology, Urology | 876.1075 | 1 |
| FDI | SNARE, FLEXIBLE | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46722 | Flexible fibreoptic cystonephroscope | An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170292521 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]