Duns Number:610322518
Device Description: Non-Stick Pads, 2 in x 3 in (5 cm x 7.6 cm)
Catalog Number
-
Brand Name
Assured
Version/Model Number
275152
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 24, 2021
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
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
97ed904c-24c4-476a-ac3e-60ae57c34d08
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
May 29, 2020
Package DI Number
20639277526483
Quantity per Package
24
Contains DI Package
00639277526489
Package Discontinue Date
July 24, 2021
Package Status
Not 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |