Catalog Number
2219
Brand Name
ADDTO
Version/Model Number
2219
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
Yes
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
EYI
Product Code Name
Adaptor, Ureteral Catheter
Public Device Record Key
17517c80-f42f-47eb-829e-6497566f460f
Public Version Date
July 23, 2020
Public Version Number
1
DI Record Publish Date
July 15, 2020
Package DI Number
00860001236026
Quantity per Package
100
Contains DI Package
00860001236002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box