DEVICE: n.a. (04048551091630)
Device Identifier (DI) Information
n.a.
26034V
In Commercial Distribution
26034V
Karl Storz GmbH & Co. KG
26034V
In Commercial Distribution
26034V
Karl Storz GmbH & Co. KG
Adaptor, for working channel
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? |
---|---|---|---|---|
61713 | Laparoscopic access cannula seal, reusable |
A small device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FAJ | Cystoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K945527 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4b310f36-5b2c-4334-93a4-d8b956ad9d70
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