Duns Number:256880576
Device Description: Procedure Mask
Catalog Number
420LFG
Brand Name
Hedy SoftMask
Version/Model Number
420LFG
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
3142700d-4cf6-46ee-a640-6b2764440df1
Public Version Date
July 16, 2020
Public Version Number
3
DI Record Publish Date
November 23, 2018
Package DI Number
D903420LFG2
Quantity per Package
6
Contains DI Package
D903420LFG1
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 | 84 |
2 | A medical device with a moderate to high risk that requires special controls. | 27 |
U | Unclassified | 2 |