DEVICE: HOPKINS (04048551216675)
Device Identifier (DI) Information
HOPKINS
8713BA
In Commercial Distribution
Karl Storz GmbH & Co. KG
8713BA
In Commercial Distribution
Karl Storz GmbH & Co. KG
HOPKINS® Telescope 30°, 5mm, 29cm
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 43946 | Rigid optical laryngopharyngoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K945788 | 000 |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Hydrogen Peroxide |
| Ethylene Oxide |
| Moist Heat or Steam Sterilization |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2fbbd59d-bc57-4038-bc97-b98da93c8d18
November 17, 2023
5
September 23, 2016
November 17, 2023
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined