Duns Number:005788130
Device Description: LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth o LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.
Catalog Number
05000-500-B
Brand Name
Linkstation MINI Evaluation Kit
Version/Model Number
Linkstation MINI Evaluation Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200665
Product Code
ONN
Product Code Name
Intraoperative Orthopedic Joint Assessment Aid
Public Device Record Key
ee113292-885b-423f-b033-8e6348988b92
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
April 28, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 171 |