Duns Number:216344051
Device Description: Specialty Absorptive, wound dressing
Catalog Number
5999BP1
Brand Name
EXU-DRY ADULT BUTTOCK PKG 10
Version/Model Number
5999BP1
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
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
bb83ca87-2735-45d5-a3c0-2dd5b6ab7fce
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2020
Package DI Number
30040565118841
Quantity per Package
10
Contains DI Package
00040565118840
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 | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |