Duns Number:303655286
Catalog Number
ESI1131
Brand Name
A.M.I. EasyShear Disposable Tips Premium
Version/Model Number
ESI1131
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182013,K182013
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
ccf08e82-35dc-462e-acbe-0f395e85f70d
Public Version Date
April 15, 2019
Public Version Number
1
DI Record Publish Date
April 05, 2019
Package DI Number
EAMIESI11311
Quantity per Package
10
Contains DI Package
EAMIESI11310
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 | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 47 |