Duns Number:534128491
Device Description: COBALT CHROME Composed Hex Abutment, 3.75 mm Diameter, 11 mm lengh
Catalog Number
P9HR-3.75,11
Brand Name
Prosthetic Accessories
Version/Model Number
P9HR-3.75,11
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
ec6d39b2-1403-4fed-924f-039449f19255
Public Version Date
May 13, 2019
Public Version Number
1
DI Record Publish Date
May 05, 2019
Package DI Number
17290111274050
Quantity per Package
10
Contains DI Package
07290111274053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 190 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |