Duns Number:315768788
Device Description: CONCO CONFORMING 4X4.1 ST 96/CS
Catalog Number
-
Brand Name
CONCO CONFORMING 4X4.1 ST 96/CS
Version/Model Number
81400000
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
9fe78cf6-aa7b-4d30-bb4e-ac866f7d5e42
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
40612553016223
Quantity per Package
12
Contains DI Package
10612553016222
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 |