Duns Number:041546137
Device Description: Claus Lucke Retinotomy Scissors With Bulbous Tip, 20 Ga, Tip Only
Catalog Number
12-2020
Brand Name
Rumex
Version/Model Number
12-2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNF
Product Code Name
Scissors, Ophthalmic
Public Device Record Key
0963ac50-67bd-41e2-8cc3-ba6c5dea6cb5
Public Version Date
June 11, 2020
Public Version Number
1
DI Record Publish Date
June 03, 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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |