Duns Number:006966006
Device Description: Double spring thumb scissors commonly used in ophthalmic procedures. This product has 6mm, Double spring thumb scissors commonly used in ophthalmic procedures. This product has 6mm, delicate, curved blades.
Catalog Number
-
Brand Name
Sklar®
Version/Model Number
64-1951
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"
Yes
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
K770040
Product Code
HNF
Product Code Name
SCISSORS, OPHTHALMIC
Public Device Record Key
1133ec26-bf8f-4022-a313-3d77c3c605d7
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
January 15, 2018
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 | 13420 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 881 |