Duns Number:876570990
Device Description: Eye Scissor Standard Blades, Pointed Tips,Curved OL104mm(3 1/2")
Catalog Number
-
Brand Name
Ophthalmic Scissors
Version/Model Number
12-47410
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HNF
Product Code Name
Scissors, Ophthalmic
Public Device Record Key
bedec032-929a-44dc-a20a-d7b77612a503
Public Version Date
July 27, 2022
Public Version Number
1
DI Record Publish Date
July 19, 2022
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 | 120 |