Duns Number:015272206
Device Description: Clear-cornea Trapezoid diamond knife, angled, 2.20mm/2.65mm wide tapered blade, sharp side Clear-cornea Trapezoid diamond knife, angled, 2.20mm/2.65mm wide tapered blade, sharp sides, j-slot titanium handle
Catalog Number
25-520E
Brand Name
Ambler Surgical
Version/Model Number
Clear-cornea Trapezoid diamond knife
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)
Yes
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
b0af1350-93a5-4e0f-b69b-03e63ac1a9be
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |