Duns Number:313446764
Device Description: Nichtedelmetall-Dental-Modellgusslegierung auf Kobalt-Basis, Typ 5 NPM - Cobalt-based dent Nichtedelmetall-Dental-Modellgusslegierung auf Kobalt-Basis, Typ 5 NPM - Cobalt-based dental casting alloy, type 512 x 1 kg
Catalog Number
-
Brand Name
GIALLOY PA
Version/Model Number
5890001 bedruckt 12 x 1 kg
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
65f190d0-4e4f-448b-bc35-cb27da095535
Public Version Date
December 07, 2018
Public Version Number
1
DI Record Publish Date
November 06, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |