Duns Number:079767953
Device Description: Combine Abdominal Pads - ABD Pads - 5’’x9’’ - High Absorbency Sterile Individually Wrapped Combine Abdominal Pads - ABD Pads - 5’’x9’’ - High Absorbency Sterile Individually Wrapped - 400
Catalog Number
5x9 ABD 400
Brand Name
Avaline Medical NJ LLC
Version/Model Number
5x9 ABD 400
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
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
e4019973-0a16-4a97-be53-a4721b8e134c
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 263 |