Duns Number:003687733
Device Description: EARLOOP, WHITE
Catalog Number
WH6155BEN
Brand Name
Critical Cover
Version/Model Number
WH6155BEN
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"
-
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
2184a2b0-f021-4760-bd69-d9cc02a53ec5
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
November 15, 2016
Package DI Number
20817583020615
Quantity per Package
10
Contains DI Package
10817583020618
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |