Duns Number:315768788
Device Description: Eze-Band Basic Sterile 3x5 36/cs
Catalog Number
-
Brand Name
Eze-Band Basic Sterile 3x5 36/cs
Version/Model Number
15800034
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
87bc6245-d607-48f8-800b-1ffdae878be9
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
June 04, 2021
Package DI Number
04052199511788
Quantity per Package
36
Contains DI Package
04052199511795
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 | 99 |
U | Unclassified | 1 |