FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04055207057599
·
Model: 732607611
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NA
- Primary DI
- 04055207057599
- Version / Model
- 732607611
- Catalog Number
- 732607611
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-21
- Public Version
- 7
- Public Version Date
- 2024-11-21
- Public Version Status
- Update
- Public Device Record Key
- d42e1b6b-0a8e-465a-81aa-646f866ed971
Device Description
FIBER-URETERORENOSCOPE BNDL
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
- No
- 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 |
|---|---|---|---|---|
| 37111 | Flexible fibreoptic ureterorenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, 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 | 04055207057599 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]