TROPHYscope
GUDID 04048551276006
CAMPO TROPHYSCOPE®
Karl Storz GmbH & Co. KG
Rigid optical hysteroscope| Primary Device ID | 04048551276006 |
| NIH Device Record Key | c718da12-bd03-43c2-883f-b1005a66ebcc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TROPHYscope |
| Version Model Number | 26008BAC |
| 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 | 04048551276006 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K971518
FDA Product Code
| HIH | HYSTEROSCOPE (AND ACCESSORIES) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
[04048551276006]
Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [TROPHYscope]
| 04048551276006 | CAMPO TROPHYSCOPE® |
| 04048551346396 | TROPHY Curette |
| 04048551261972 | Continuous-Flow Operating Sheath |
| 04048551258262 | Continuous-Flow Operating Sheath |
Trademark Results [TROPHYscope]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TROPHYSCOPE 79100466 4123782 Live/Registered |
KARL STORZ SE & Co. KG 2011-03-02 |
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