Duns Number:216344051
Device Description: Specialty, absorptive wound dressing.
Catalog Number
5999LV1
Brand Name
EXU-DRY LARGE BURN VEST CTN 20
Version/Model Number
5999LV1
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
4065bd13-dfc9-4273-9c44-bc11088cc01b
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
April 09, 2020
Package DI Number
30040565118810
Quantity per Package
20
Contains DI Package
00040565118819
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 |