Catalog Number
2216
Brand Name
ADDTO
Version/Model Number
2216
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"
Yes
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
KIC
Product Code Name
Cushion, Flotation
Public Device Record Key
58d54496-0466-4c5f-9e1e-5f4d85524b79
Public Version Date
July 23, 2020
Public Version Number
1
DI Record Publish Date
July 15, 2020
Package DI Number
00860001236071
Quantity per Package
12
Contains DI Package
00860001236064
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box