Duns Number:040729840
Device Description: LIPPMAN NUCLEUS SPATULA BLUNT FORKED ROUND CURVED ANGLED TIP STAINLESS STEEL
Catalog Number
12-2730
Brand Name
LIPPMAN NUCLEUS SPATULA
Version/Model Number
12-2730
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
HND
Product Code Name
Spatula, ophthalmic
Public Device Record Key
bb2b55e4-ddc4-40e4-85fc-b93c982e6d52
Public Version Date
February 24, 2020
Public Version Number
5
DI Record Publish Date
September 18, 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 |