Duns Number:812762226
Device Description: 5.2 mm Implant Knife Angled, Bevel Up
Catalog Number
76-5261
Brand Name
Sharpoint
Version/Model Number
76-5261
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
Yes
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
5432af5e-485a-41a6-8deb-626e8b1bb4bb
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 21, 2021
Package DI Number
10848782028808
Quantity per Package
6
Contains DI Package
00848782028801
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |