Duns Number:137217043
Catalog Number
106-5032
Brand Name
ENDO-SAVER ICE REFRIGERANT SPRAY 10oz CAN
Version/Model Number
106-5032
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K930764,K930764
Product Code
EAT
Product Code Name
Tester, Pulp
Public Device Record Key
f4032674-fd4e-47dc-9d01-5c201bc529b7
Public Version Date
August 26, 2020
Public Version Number
4
DI Record Publish Date
June 02, 2017
Package DI Number
D77810650321
Quantity per Package
12
Contains DI Package
D77810650320
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |