Duns Number:831375089
Device Description: PremierPro MRI Safe Earloop Masks, 50 per box
Catalog Number
2497
Brand Name
PremierPro
Version/Model Number
2497
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123787,K123787
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
96b84307-aa9a-4341-b6fb-d7990b636862
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 2022
Package DI Number
00811220033712
Quantity per Package
6
Contains DI Package
00811220033729
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |