RIWO D-URS 473572086
GUDID 04055207070437
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
Richard Wolf GmbH
Rigid video ureterorenoscope| Primary Device ID | 04055207070437 |
| NIH Device Record Key | e483fc48-93ad-4672-aec7-0bc00574d6b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIWO D-URS |
| Version Model Number | 473572086 |
| Catalog Number | 473572086 |
| Company DUNS | 315304071 |
| Company Name | Richard Wolf GmbH |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com | |
| Phone | +497043350 |
| info@richard-wolf.com |
Device Dimensions
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
| Outer Diameter | 3 Millimeter |
| Length | 600 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04055207070420 [Primary] |
| GS1 | 04055207070437 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201897
FDA Product Code
| FGB | Ureteroscope and accessories, flexible/rigid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2025-04-15 |
On-Brand Devices [RIWO D-URS]
| 04055207064184 | SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1, |
| 04055207070437 | SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6 Fr, working channel 2: 1, |
Trademark Results [RIWO D-URS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RIWO D-URS 88891315 not registered Live/Pending |
Richard Wolf GmbH 2020-04-28 |
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