Duns Number:830016148
Device Description: 3M™ ESPE™ Xerostomia Relief Spray, Sample Pack, 9 Canisters, 12136
Catalog Number
12136
Brand Name
3M™ ESPE™
Version/Model Number
12136
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LFD
Product Code Name
SALIVA, ARTIFICIAL
Public Device Record Key
b5ad6f31-4643-4d18-998f-e43a09b3e0e8
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
October 31, 2018
Package DI Number
50348878600010
Quantity per Package
12
Contains DI Package
30348878600016
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |