Duns Number:527333326
Device Description: New Sil-Flex Silicone Mask size 3, Child Large
Catalog Number
-
Brand Name
Sil-Flex
Version/Model Number
5181
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
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
b686b1c3-c85f-4a9c-96a9-da5cea5ee4f7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2015
Package DI Number
24710810083192
Quantity per Package
2
Contains DI Package
04710810083198
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |