Duns Number:068586441
Device Description: Cohesive Bandage Latex Tan 2 x 5 yds 36/Bx
Catalog Number
783025
Brand Name
Dealmed
Version/Model Number
783025
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
d78c1294-5788-4620-8b9d-99dc460f3f80
Public Version Date
September 06, 2022
Public Version Number
1
DI Record Publish Date
August 29, 2022
Package DI Number
10817415022247
Quantity per Package
36
Contains DI Package
00817415022240
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |