Duns Number:061081477
Device Description: MASK EARLP S/P FLUID RESIST BL*50 #658-00310
Catalog Number
SP440068
Brand Name
SmartPractice
Version/Model Number
SP440068
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"
-
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
aa58aedb-ece0-4df3-ae91-7a64a4b0a009
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 08, 2016
Package DI Number
D766SP4400682
Quantity per Package
40
Contains DI Package
D766SP4400681
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| U | Unclassified | 18 |