DEVICE: n.a. (04048551045565)
Device Identifier (DI) Information
n.a.
10316LR
In Commercial Distribution
10316LR
Karl Storz GmbH & Co. KG
10316LR
In Commercial Distribution
10316LR
Karl Storz GmbH & Co. KG
Adaptor, for 10316 AS-DS
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? |
---|---|---|---|---|
64640 | Endoscope channel-opening adaptor |
A small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K943700 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
83dba1fd-f40b-4578-95c1-cc7baafd3e91
March 19, 2024
4
September 23, 2016
March 19, 2024
4
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
[?]
+14242188201
regulatory@karlstorz.com
regulatory@karlstorz.com