Duns Number:002144145
Catalog Number
4901
Brand Name
ETHICON OMNEX
Version/Model Number
4901
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 18, 2019
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
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
NBE
Product Code Name
Sealant,polymerizing
Public Device Record Key
80eca7be-7529-4a2f-b81d-eb83d8fbd949
Public Version Date
July 19, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2014
Package DI Number
30705031133109
Quantity per Package
4
Contains DI Package
10705031133105
Package Discontinue Date
July 18, 2019
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |