Duns Number:830016148
Device Description: 3M™ ESPE™ Express™ VPS Impression Material Light Body Fast Set Bulk Pack, 7301T
Catalog Number
7301T
Brand Name
Express™
Version/Model Number
7301T
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
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
4a17ee80-03a9-45ce-98eb-325f93f004e2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 24, 2017
Package DI Number
50605861010899
Quantity per Package
5
Contains DI Package
30605861010895
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 |