Duns Number:738288096
Catalog Number
-
Brand Name
Toric IOL Marker 11mm Wide
Version/Model Number
91-6002
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
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
-
Product Code
HMR
Product Code Name
Marker, Ocular
Public Device Record Key
4e595da4-7899-4f2f-b9b4-0d555a0e284f
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
05060480402775
Quantity per Package
10
Contains DI Package
05060480408272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |