Duns Number:079163089
Device Description: Tissue Adhesive with Dauber/Nozzle ANDderma+flex QS SourceMark, 0.7g product code M1201 an Tissue Adhesive with Dauber/Nozzle ANDderma+flex QS SourceMark, 0.7g product code M1201 and M1201-01
Catalog Number
QS70806
Brand Name
derma+flex QS
Version/Model Number
QS70806
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101276,K101276,K101276,K101276,K101276
Product Code
MPN
Product Code Name
Tissue Adhesive For The Topical Approximation Of Skin
Public Device Record Key
e24b952d-2102-4947-95c9-7faed11257ba
Public Version Date
May 18, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10854137001174
Quantity per Package
6
Contains DI Package
00854137001177
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |