FDA UDI
Not in Commercial Distribution
🇺🇸 United States
COBRA VISION EF
DI: 04055207054949
·
Model: 73561071
·
Richard Wolf GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COBRA VISION EF
- Primary DI
- 04055207054949
- Version / Model
- 73561071
- Catalog Number
- 73561071
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-23
- Public Version
- 5
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 80358a52-566f-4939-a518-42c687cf0208
- Distribution End Date
- 2024-01-01
Device Description
SENSOR-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3,6FR, working channel 2: 2.4FR, double slanted distal tip Ø 5,2FR, TL 980mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, two function buttons, for connection to ENDOCAM Flex HD, LED-illumination, distal Sensor, Fixfocus
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
- Yes
- Sterilization Methods
- Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGB | Ureteroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FGA | Kit, nephroscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38703 | Flexible video ureterorenoscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207054949 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.3 | Millimeter | |
| Length | 680 | Millimeter |