Duns Number:830016148
Device Description: 3M™ High-Resolution Scanning Spray – 3.75g Bottle, 68960
Catalog Number
68960
Brand Name
3M™
Version/Model Number
68960
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
NOF
Product Code Name
System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations
Public Device Record Key
77b94616-459a-4db9-99cb-8c7e233aa558
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50605861038534
Quantity per Package
10
Contains DI Package
30605861038530
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 |