Primary Device ID | 04048551422625 |
NIH Device Record Key | d5616fd1-abfd-4ac9-900f-b517a94853dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMAGE1 S CONNECT |
Version Model Number | TC201US |
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 | 04048551422625 [Primary] |
GWG | Endoscope, neurological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-10 |
Device Publish Date | 2020-03-02 |
04048551232378 - n.a. | 2025-08-19 Urethrotome Sheath, 8 Fr. |
04048551232781 - n.a. | 2025-08-19 Urethrotome Sheath, 10 Fr. |
04048551418123 - n.a. | 2025-08-19 IMAGE1 S 4U-LINK |
04048551210567 - n.a. | 2025-08-12 Injection Cannula, diam. 2 mm |
04048551210574 - n.a. | 2025-08-12 Injection Cannula, diam. 3 mm |
04048551211281 - n.a. | 2025-08-12 Injection Cannula, 8.5 cm |
04048551211427 - n.a. | 2025-08-12 Injection Cannula |
04048551211694 - n.a. | 2025-08-12 Injection Cannula, 8.5 cm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IMAGE1 S CONNECT 87002820 5418853 Live/Registered |
Karl Storz Endoscopy-America, Inc. 2016-04-15 |