Duns Number:041546137
Device Description: Side-Port Sapphire Knife, 45° Double-Edge Blade, 1.00 mm, Length 136 mm, Straight Titanium Side-Port Sapphire Knife, 45° Double-Edge Blade, 1.00 mm, Length 136 mm, Straight Titanium Handle
Catalog Number
6-10/6SK-0501
Brand Name
Rumex
Version/Model Number
6-10/6SK-0501
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
HNN
Product Code Name
Knife, Ophthalmic
Public Device Record Key
a3049745-d858-417a-acc3-8b2bd1b85606
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 02, 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 |