Duns Number:041546137
Device Description: Diamond Knife For Arcuate Incisions 1.00/0.20 mm Tapered Blade, Length 110 mm, Micrometric Diamond Knife For Arcuate Incisions 1.00/0.20 mm Tapered Blade, Length 110 mm, Micrometric Titanium Handle
Catalog Number
6-00/6-030
Brand Name
Rumex
Version/Model Number
6-00/6-030
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
34ce5a0f-8ab6-48af-8b0f-2e59323a54ef
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 |