Duns Number:879324241
Device Description: LANCE TIP KNIFE 22.5°, SAFETY
Catalog Number
-
Brand Name
Ophthalmic Knife
Version/Model Number
OVS61225
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
6f329ef9-a338-4329-a24c-d4e0bed95109
Public Version Date
January 17, 2022
Public Version Number
1
DI Record Publish Date
January 07, 2022
Package DI Number
08903317020315
Quantity per Package
6
Contains DI Package
08903317013706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 161 |