Primary Device ID | 04048551356517 |
NIH Device Record Key | ec53b54c-1740-4709-9721-1209ae690d81 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMAGE1 H3-LINK |
Version Model Number | TC300US |
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 | 04048551356517 [Primary] |
FET | Endoscopic video imaging system/component, gastroenterology-urology |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-05-19 |
Device Publish Date | 2016-09-23 |
04048438000984 - n.a. | 2024-03-19 Patient Tubing Set, for day sets |
04048438001042 - n.a. | 2024-03-19 Tubing Set, UNIDRIVE/UNIDRIVE SIII |
04048438001233 - n.a. | 2024-03-19 Gas filter, gas flow 30 l/min |
04048438002230 - n.a. | 2024-03-19 Tubing Set, CLEARVISION II (irrigation) |
04048438002964 - n.a. | 2024-03-19 Tubing Set, ARTHROPUMP Power(irrigation) |
04048438003176 - n.a. | 2024-03-19 Pump Tubing Day Set |
04048438005316 - n.a. | 2024-03-19 Insufflation Tubing Set, with gas filter |
04048438005330 - n.a. | 2024-03-19 Insufflation tubing set, ENDOFLATOR 50 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMAGE1 H3-LINK 85806539 4625510 Live/Registered |
Karl Storz Endoscopy-America, Inc. 2012-12-19 |