DEVICE: n.a. (04048551225813)
Device Identifier (DI) Information
n.a.
11101SK2
In Commercial Distribution
Karl Storz GmbH & Co. KG
11101SK2
In Commercial Distribution
Karl Storz GmbH & Co. KG
Rhino-Laryngo-Fiberscope, 2.5 x 270 mm
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? |
---|---|---|---|---|
44715 | Flexible fibreoptic nasopharyngolaryngoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. 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 [?] |
---|---|
K950338 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Hydrogen Peroxide |
Liquid Chemical |
Ethylene Oxide |
Peracetic Acid |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
cb4154eb-61fb-4cc6-888c-c9d018203e96
July 06, 2018
3
September 23, 2016
July 06, 2018
3
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