Duns Number:135872476
Device Description: WoundSeal® MD + Applicator
Catalog Number
NPS001
Brand Name
WoundSeal®
Version/Model Number
NPS001
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070520,K080210,K070520,K080210,K070520,K080210
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
1e2965e1-5815-4415-9575-76b036b30a1d
Public Version Date
April 20, 2022
Public Version Number
3
DI Record Publish Date
January 28, 2022
Package DI Number
00834061000613
Quantity per Package
6
Contains DI Package
00834061000057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 2 |