Duns Number:051420107
Device Description: Surgical Mask w/Ties Blue MMC
Catalog Number
-
Brand Name
Moore Medical
Version/Model Number
82668
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061864,K061864,K061864
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
f0eb894a-59c4-4620-a53b-f667fb9e5c8b
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
December 09, 2016
Package DI Number
40607415001509
Quantity per Package
6
Contains DI Package
20607415001499
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |