FDA UDI
In Commercial Distribution
🇺🇸 United States
MAMBA VISION
DI: 04055207063477
·
Model: 7315006
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAMBA VISION
- Primary DI
- 04055207063477
- Version / Model
- 7315006
- Catalog Number
- 7315006
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 6
- Public Version Date
- 2021-04-23
- Public Version Status
- Update
- Public Device Record Key
- 75e05619-7f66-448e-ad9a-5e4af96b418c
Device Description
SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, control lever to distal – upward DEF, for connection to ENDOCAM Logic HD and ENDOCAM Logic HD lite 5525, 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 |
|---|---|---|---|---|
| FAJ | Cystoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44925 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207063477 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 400 | Millimeter |