Duns Number:832637081
Device Description: TRIAL HEAD SIZE 46
Catalog Number
E511446
Brand Name
NA
Version/Model Number
E5114-46
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
-
Product Code
HWT
Product Code Name
TEMPLATE
Public Device Record Key
6ee6c532-a041-4aab-8a6d-012b9c66f1c8
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
February 20, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1194 |
2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
3 | A medical device with high risk that requires premarket approval | 30 |
U | Unclassified | 1 |