Duns Number:058614483
Device Description: Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
Catalog Number
CB-CO-4 x 5
Brand Name
ClosureFast
Version/Model Number
CB-CO-4 x 5
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
-
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
ead399db-b0f5-492f-9ef9-feecd47afc21
Public Version Date
November 13, 2018
Public Version Number
1
DI Record Publish Date
October 13, 2018
Package DI Number
20884521140209
Quantity per Package
144
Contains DI Package
10884521140202
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |