Duns Number:880141023
Device Description: Nu Alloy dp40 Caps. Jar X 500 - 1 Spill
Catalog Number
0013416
Brand Name
Nu Alloy dp40 Caps. Jar X 500 - 1 Spill
Version/Model Number
0013416
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
K140125
Product Code
EJJ
Product Code Name
Alloy, Amalgam
Public Device Record Key
9c5b3afc-cf2e-46aa-9c8d-85b344b6512c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2017
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. | 94 |