Duns Number:880141023
Device Description: Nu Alloy dp Caps. Jar X 500 - 2 Spill
Catalog Number
87030
Brand Name
Nu Alloy dp Caps. Jar X 500 - 2 Spill
Version/Model Number
87030
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
d719bb06-2b2f-4a1d-9856-b168dfe7a75c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 23, 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 |