Duns Number:056038268
Catalog Number
-
Brand Name
Miller™
Version/Model Number
5069-56
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)
Yes
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
KIH
Product Code Name
DISPENSER, CEMENT
Public Device Record Key
b9453b1d-d3e7-4a14-89ab-e20caf161727
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 2016
Package DI Number
00889024379824
Quantity per Package
10
Contains DI Package
00889024376694
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8464 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20880 |
| 3 | A medical device with high risk that requires premarket approval | 133 |