Duns Number:135872476
Device Description: WoundSeal® + Applicator
Catalog Number
QSO010ZC
Brand Name
WoundSeal®
Version/Model Number
QSO010ZC
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
d5e822f9-6641-43a7-9ba7-89f687a7e96e
Public Version Date
April 20, 2022
Public Version Number
3
DI Record Publish Date
January 28, 2022
Package DI Number
00834061000118
Quantity per Package
144
Contains DI Package
00834061000446
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 2 |