Duns Number:315731711
Device Description: 3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414
Catalog Number
69414
Brand Name
Impregum™ Penta™ Super Quick
Version/Model Number
69414
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
EFD
Product Code Name
AMALGAMATOR, DENTAL, AC-POWERED
Public Device Record Key
f85894e0-ebfd-4566-a522-891cf1bee6b1
Public Version Date
September 22, 2020
Public Version Number
4
DI Record Publish Date
November 14, 2018
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 |