Duns Number:080125056
Device Description: Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG- Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
Catalog Number
-
Brand Name
MICOR extractor
Version/Model Number
FG-50621
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200584,K200584,K200584
Product Code
HQC
Product Code Name
Unit, Phacofragmentation
Public Device Record Key
950eb7cd-38a1-47d1-8341-09b3335aa9ca
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
Package DI Number
30860000122369
Quantity per Package
4
Contains DI Package
00860000122368
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Cardboard
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |