Duns Number:040729840
Device Description: NUCLEUS SPLITTER FORCEPS CROSS ACTION CROSS SERRATED TIP SHORT HANDLE TITANIUM
Catalog Number
T14-5372
Brand Name
NUCLEUS SPLITTER FORCEPS
Version/Model Number
T14-5372
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
HNR
Product Code Name
Forceps, ophthalmic
Public Device Record Key
2392d460-e202-4fa7-a265-f01fb8ebbc48
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 19, 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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |