Duns Number:830016148
Device Description: 3M™ ESPE™ Disposable Applicator Brush Tips, 1919B
Catalog Number
1919B
Brand Name
3M™ ESPE™
Version/Model Number
1919B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXR
Product Code Name
APPLICATOR, RESIN
Public Device Record Key
3330f753-fdff-4d7e-b598-caa5ed5802bc
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50605861026319
Quantity per Package
10
Contains DI Package
30605861026315
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 |