Duns Number:511268005
Device Description: HISTOACRYL CLEAR SKIN ADHESIVE (FP)
Catalog Number
TS1050071FP
Brand Name
AESCULAP
Version/Model Number
TS1050071FP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2022
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
b76c341f-5253-4a25-966d-5bcb61f77be0
Public Version Date
February 28, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |