Flex-X
GUDID 04048551416969
Video Uretero-Renoscope FLEX-X C
Karl Storz GmbH & Co. KG
Flexible video ureterorenoscope, reusable| Primary Device ID | 04048551416969 |
| NIH Device Record Key | 69ab09b7-bd18-4ac3-af21-b666ea861866 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flex-X |
| Version Model Number | 11278VSUE |
| Company DUNS | 315731430 |
| Company Name | Karl Storz GmbH & Co. KG |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048551416969 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141250
FDA Product Code
| FGB | Ureteroscope and accessories, flexible/rigid |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
[04048551416969]
Peracetic Acid;Ethylene Oxide;High-level Disinfectant;Hydrogen Peroxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2020-01-11 |
On-Brand Devices [Flex-X]
| 04048551416976 | Video Uretero-Renoscope FLEX-X C |
| 04048551416969 | Video Uretero-Renoscope FLEX-X C |
| 04048551402634 | Video Uretero-Renoscope, FLEX-X C |
| 04048551278239 | Video Uretero-Renoscope, FLEX-X C |
| 04048551338988 | Video Neuro-Endoscope, flexible |
| 04048551402580 | Video Uretero-Renoscope, FLEX-X C |
| 04048551276884 | Video Uretero-Renoscope, FLEX-X C |
| 04048551402573 | Uretero-Reno-Fiberscope FLEX-X² |
| 04048551402504 | Pediat. Cysto-Urethro-Fiberscope FLEX-X |
| 04048551226438 | Uretero-Reno-Fiberscope FLEX-X² |
| 04048551226377 | Pediat. Cysto-Urethro-Fiberscope, FLEX-X |
| 04048551226353 | Pediat. Cysto-Urethro-Fiberscope, FELX-X |
| 04048551226339 | Uretero-Reno-Fiberscope FLEX-X² |
Trademark Results [Flex-X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEX-X 78275852 2979037 Live/Registered |
KARL STORZ SE & CO. KG 2003-07-18 |
 FLEX-X 74390569 1839650 Dead/Cancelled |
Panhandle Eastern Corporation 1993-05-14 |
 FLEX-X 73629233 1470416 Live/Registered |
WIRE ROPE CORPORATION OF AMERICA, INC. 1986-11-07 |
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