Duns Number:689667152
Device Description: It is a device that confirms the direction of the placed fixture.
Catalog Number
-
Brand Name
Surgical Kit
Version/Model Number
DP00S
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
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
782640dc-e9c3-44a8-8a58-22d0fc46430f
Public Version Date
October 21, 2022
Public Version Number
1
DI Record Publish Date
October 13, 2022
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 | 542 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |