Duns Number:830016148
Device Description: 3M™ Tie-on Surgical Masks, 50/box, 1818
Catalog Number
1818
Brand Name
3M™
Version/Model Number
1818
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
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
-
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
574f84fc-54fe-4861-a6a3-0b1e831b57e1
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
August 26, 2017
Package DI Number
50707387783193
Quantity per Package
12
Contains DI Package
30707387783199
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |