Duns Number:008018525
Device Description: 27+® FINESSE® Flex Loop DSP
Catalog Number
-
Brand Name
Alcon Grieshaber 27+ Finesse
Version/Model Number
338.27
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"
Yes
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
-
Product Code
HNQ
Product Code Name
Hook, ophthalmic
Public Device Record Key
c29909b1-9ee0-432d-9558-cccfbc25584a
Public Version Date
August 27, 2020
Public Version Number
1
DI Record Publish Date
August 19, 2020
Package DI Number
17612717071459
Quantity per Package
6
Contains DI Package
07612717071452
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 | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |