Duns Number:040679649
Device Description: silicone sheet firm
Catalog Number
-
Brand Name
Technical Products
Version/Model Number
502-3 12x12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K971472
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
f9d2a989-5e96-45c0-84af-506530df7a35
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 28, 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. | 211 |