Duns Number:088528245
Device Description: Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, CPK, 4" X 5 Y Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, CPK, 4" X 5 Yds
Catalog Number
5400CP-018
Brand Name
Coflex NL
Version/Model Number
CPK, 4" X 5 Yds
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)
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
dcc79313-272f-4087-9746-e85fedc4d353
Public Version Date
April 13, 2022
Public Version Number
1
DI Record Publish Date
April 05, 2022
Package DI Number
00724004541153
Quantity per Package
18
Contains DI Package
10724004541150
Package Discontinue Date
-
Package Status
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 | 55 |