Duns Number:079163089
Device Description: HVTSA 1g AND exofin HVTSA SourceMark, 1g product code M1205 and M1205-01
Catalog Number
EX70410
Brand Name
exofin HVTSA, 1g
Version/Model Number
EX70410
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MPN
Product Code Name
Tissue Adhesive For The Topical Approximation Of Skin
Public Device Record Key
9aaa1325-5f2d-4d82-b359-c31a46602c65
Public Version Date
May 18, 2022
Public Version Number
3
DI Record Publish Date
October 29, 2021
Package DI Number
10854137001624
Quantity per Package
10
Contains DI Package
00854137001627
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| 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 |