Duns Number:315768788
Device Description: FLEXICON ST 2X4.1 96/CS
Catalog Number
-
Brand Name
FLEXICON ST 2X4.1 96/CS
Version/Model Number
19200000
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
5273cd62-1ebc-48f3-a150-51e8e9906690
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
20612553013204
Quantity per Package
96
Contains DI Package
10612553013207
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 |