Duns Number:091356894
Device Description: SCI Sty 7 Sz 3 Clear-F NS
Catalog Number
600-703-55-30-8A
Brand Name
AART Silicone Carving Block
Version/Model Number
A
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021820
Product Code
MIB
Product Code Name
ELASTOMER, SILICONE BLOCK
Public Device Record Key
acec7474-a2f7-45f8-9011-72b7ef7eaeb3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 20, 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. | 371 |