Duns Number:606864184
Device Description: Size #5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality r
Catalog Number
280050
Brand Name
EndoMask Elite®
Version/Model Number
Size #5 - 280050
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
afa2f209-2282-4973-8cbf-4b126f261562
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 30, 2017
Package DI Number
10182151000003
Quantity per Package
5
Contains DI Package
00182151000006
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 |