RIWO D-URS 473572076
GUDID 04055207064184
SENSOR-URETERORENOSCOPE 9FR WL 600MM flexible, working channel 1: 3,6FR, working channel 2: 1,65FR, PU= 3 pcs, sterile, for single use
Richard Wolf GmbH
Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope Rigid video ureterorenoscope| Primary Device ID | 04055207064184 |
| NIH Device Record Key | 8292d003-822f-4b30-9dc2-5472364b52f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIWO D-URS |
| Version Model Number | 473572076 |
| Catalog Number | 473572076 |
| 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 | true |
| 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
Device Dimensions
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 | 04055207064177 [Primary] |
| GS1 | 04055207064184 [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 | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
Devices Manufactured by Richard Wolf GmbH
| 04055207069776 - NA | 2024-04-09 SEAL Ø 11MM silicone seal, blue, for instruments 3-6mm, Length 2mm, reusable |
| 04055207069783 - NA | 2024-04-09 SEALING MEMBRANE Ø 17MM yellow, Ø 17mm, PACK=10 PCS, for instruments from 3 to 6mm |
| 04055207056691 - NA | 2024-04-08 LASER WORKING ELEMENT PASSIVE 12/30° closed, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayon |
| 04055207056707 - NA | 2024-04-08 LASER WORKING INSERT 12/30° compatible with telescopes Ø 4mm, with locking mechanism for laser fiber, bayonet-lock, reusable |
| 04055207057247 - NA | 2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 22FR with lateral guide, distal end straight, reusable |
| 04055207057254 - NA | 2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 24FR with lateral guide, distal end straight, reusable |
| 04055207057261 - NA | 2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 22FR with lateral guide, distal end straight, reusable |
| 04055207057278 - NA | 2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 24FR with lateral guide, distal end straight, reusable |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.