Duns Number:015108087
Device Description: MASKS NAT EXT EAR CURVE BLU 50
Catalog Number
-
Brand Name
NATURAL EXTENSIONS
Version/Model Number
3414-717
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
7c08a40e-0842-4422-9e75-23da378c69a8
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
November 16, 2016
Package DI Number
10366975002027
Quantity per Package
50
Contains DI Package
00366975002020
Package Discontinue Date
-
Package Status
-
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1364 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 377 |
| U | Unclassified | 15 |