Duns Number:809555139
Device Description: Toric IOL Reference Marker, Conical Micro-Teeth Positioned at 0, 90, and 180 Degrees, Stai Toric IOL Reference Marker, Conical Micro-Teeth Positioned at 0, 90, and 180 Degrees, Stainless Steel
Catalog Number
-
Brand Name
Diamatrix
Version/Model Number
M24400
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
-
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
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
721c7301-1908-4ae0-976e-bb77f4984773
Public Version Date
November 01, 2019
Public Version Number
1
DI Record Publish Date
October 24, 2019
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 475 |
U | Unclassified | 13 |