FDA UDI
In Commercial Distribution
🇺🇸 United States
RIWO D-URS
DI: 04055207070420
·
Model: 473572086
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- RIWO D-URS
- Primary DI
- 04055207070420
- Version / Model
- 473572086
- Catalog Number
- 473572086
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2025-04-15
- Public Version
- 2
- Public Version Date
- 2025-10-15
- Public Version Status
- Update
- Public Device Record Key
- e483fc48-93ad-4672-aec7-0bc00574d6b5
Device Description
SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6 Fr, working channel 2: 1,65 Fr, PACK = 3 pcs., can be used with vacuum aspiration and irrigation devices up to a maximum suction range of -450 mmHg/-60 kPa, sterile, for single use
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGB | Ureteroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63516 | Rigid video ureterorenoscope | An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted by a video system via an image sensor chip at the distal end of the endoscope and displayed on a monitor. This device is typically used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04055207070437 | GS1 | ||||
| Primary | 04055207070420 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201897 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.0 | Millimeter | |
| Length | 600.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius