Duns Number:012430880
Device Description: Maxima Diamond FG 879K-016C
Catalog Number
9007390
Brand Name
Henry Schein
Version/Model Number
9007390
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
DZP
Product Code Name
INSTRUMENT, DIAMOND, DENTAL
Public Device Record Key
44d87c8e-f9a5-4c9b-933e-065c530f8b8f
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
December 30, 2019
Package DI Number
20304040035201
Quantity per Package
10
Contains DI Package
10304040035204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |