Duns Number:407522184
Catalog Number
3445.18SF1
Brand Name
MICS 1.8 mm Reusable phaco set with 45° straight flared needle
Version/Model Number
3445.18SF1
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
K190875,K190875
Product Code
HQC
Product Code Name
Unit, Phacofragmentation
Public Device Record Key
321ea508-cc1c-4e42-8e1a-eca7842b4336
Public Version Date
March 19, 2020
Public Version Number
2
DI Record Publish Date
February 10, 2020
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 | 203 |
2 | A medical device with a moderate to high risk that requires special controls. | 149 |