DEVICE: Flex-X (04048551276884)
Device Identifier (DI) Information
Flex-X
11278V
In Commercial Distribution
Karl Storz GmbH & Co. KG
11278V
In Commercial Distribution
Karl Storz GmbH & Co. KG
Video Uretero-Renoscope, FLEX-X C
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 38703 | Flexible video ureterorenoscope, reusable |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FGB | Ureteroscope and accessories, flexible/rigid |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K131369 | 000 |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Hydrogen Peroxide |
| Peracetic Acid |
| Ethylene Oxide |
| Liquid Chemical |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
eb8a65ea-d85a-4566-a17a-d8e9a20a5d02
May 10, 2021
5
September 23, 2016
May 10, 2021
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined