Duns Number:144008062
Device Description: PINNACLE LITE BASIC KIT
Catalog Number
SL300
Brand Name
PINNACLE LITE
Version/Model Number
SL300
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PCD
Product Code Name
Powered stairway chair lift
Public Device Record Key
c421d6dd-2656-4e9c-9321-22f1ecc79548
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 19, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 544 |