Duns Number:041546137
Device Description: LASEK 9mm Trephine / 9.5mm Funnel, Depth of the incision 70 mkm, Length 130 mm, Round Tit LASEK 9mm Trephine / 9.5mm Funnel, Depth of the incision 70 mkm, Length 130 mm, Round Titanium Handle
Catalog Number
20-122
Brand Name
Rumex
Version/Model Number
20-122
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
HRH
Product Code Name
Trephine, Manual, Ophthalmic
Public Device Record Key
3b4fd0ed-36bd-4a70-b3ee-19c1816b7346
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 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 |