Duns Number:606864184
Device Description: Size #4, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high qualit
Catalog Number
280040
Brand Name
EndoMask Elite®
Version/Model Number
Size #4 - 280040
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
d319da99-148b-46e5-9da2-0ed06ea6e794
Public Version Date
August 01, 2018
Public Version Number
3
DI Record Publish Date
May 30, 2017
Package DI Number
10182151000010
Quantity per Package
5
Contains DI Package
00182151000013
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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 54 |