Duns Number:169895245
Catalog Number
-
Brand Name
EasyTouch
Version/Model Number
627155
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
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
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
3803aaaf-56d4-4cf9-95e4-e42a04a15038
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 10, 2016
Package DI Number
MHC16271552
Quantity per Package
100
Contains DI Package
MHC16271551
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 184 |