Duns Number:068586441
Device Description: Conforming Stretch Bandage N/S LF Polyester 2" x 4.1 yds 12/Box
Catalog Number
783102
Brand Name
Dealmed
Version/Model Number
817415020123
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
f861fa9e-62b9-46b2-9823-d7890a561718
Public Version Date
October 02, 2020
Public Version Number
2
DI Record Publish Date
September 11, 2020
Package DI Number
00817415020123
Quantity per Package
8
Contains DI Package
00817415020116
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |