DEVICE: n.a. (04048551110867)
Device Identifier (DI) Information
n.a.
28229DR
In Commercial Distribution
Karl Storz GmbH & Co. KG
28229DR
In Commercial Distribution
Karl Storz GmbH & Co. KG
High-Flow Arthroscope Sheath, 6.5/12
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Rigid endoscope sheath, reusable | A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | ARTHROSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K943154 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fa8b5781-94ad-4457-8eea-b9fae3e85326
July 24, 2018
4
September 23, 2016
July 24, 2018
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
[?]
No Customer Contact currently defined