Duns Number:315731711
Device Description: 3M™ ESPE™ Imprint™ 4 Super Quick VPS Preliminary Impression Material Economy Pack, 10 - 50 3M™ ESPE™ Imprint™ 4 Super Quick VPS Preliminary Impression Material Economy Pack, 10 - 50 ml Cartridges, 71540 DM DI = 04035077018777
Catalog Number
71540
Brand Name
Imprint™ 4 Preliminary Super Quick
Version/Model Number
71540
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
54884065-e3e8-4117-9473-84d5cc59a552
Public Version Date
December 07, 2018
Public Version Number
3
DI Record Publish Date
August 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |