Duns Number:091356894
Device Description: Szr - Malar Sty 2 Sz 2 R NS
Catalog Number
401-202-6-2A
Brand Name
AART Malar Implant Sizer
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
K021419
Product Code
LZK
Product Code Name
IMPLANT, MALAR
Public Device Record Key
d15abf40-b353-46b1-8b42-c2b6f186d3a6
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 |