Duns Number:037933645
Device Description: Arm Boards
Catalog Number
-
Brand Name
Pinestar Technology Inc
Version/Model Number
NMC-SAB
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
NOD
Product Code Name
Board, Arm (With Cover), Non-Sterile
Public Device Record Key
0c2e10a7-02e2-4172-94ce-73bd2ddbd927
Public Version Date
July 31, 2020
Public Version Number
1
DI Record Publish Date
July 23, 2020
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 | 47 |