| Primary Device ID | 04048551344408 |
| NIH Device Record Key | b6294189-463f-4188-8f53-2cb854df494b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flex-X / IMAGE 1 S |
| Version Model Number | 11278VS |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04048551344408 [Primary] |
| FGB | Ureteroscope and accessories, flexible/rigid |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
[04048551344408]
Hydrogen Peroxide;Ethylene Oxide;Liquid Chemical;Peracetic Acid
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2024-08-19 |
| Device Publish Date | 2016-09-23 |
| 04048551402597 | Vid. Uretero-Renoscope FLEX-XC |
| 04048551344385 | Video Uretero-Renoscope FLEX-XC |
| 04048551402603 | Vid. Uretero-Renoscope FLEX-XC |
| 04048551344408 | Video Uretero-Renoscope FLEX-XC |