| Primary Device ID | 04048551356876 |
| NIH Device Record Key | b4929217-54af-4f27-b5e7-8e9a1c40a8eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMAGE 1 S |
| Version Model Number | TH116 |
| 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 | 04048551356876 [Primary] |
| FET | Endoscopic video imaging system/component, gastroenterology-urology |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
[04048551356876]
Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide;Peracetic Acid
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-08-19 |
| Device Publish Date | 2017-02-10 |
| 04048551333150 | IMAGE1 S H3-Z FI |
| 04048551370506 | IMAGE1 S 4U |
| 04048551356876 | IMAGE1 S D1 |
| 04048551333976 | IMAGE1 S H3-P |
| 04048551333969 | IMAGE1 S H3-ZA |
| 04048551333143 | IMAGE1 S H3-ZI |
| 04048551349779 | Video Choledochoscope IMAGE1 S |