Duns Number:007883297
Device Description: #16-Teardrop Dissector, 90°, 3mm Tip, 230mm Length
Catalog Number
-
Brand Name
#16-Teardrop Dissector, 90°, 3mm Tip, 230mm Length
Version/Model Number
N7116E-K
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)
-
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
d6d5ea37-6fb3-4a6a-9467-b355fe9494a6
Public Version Date
May 20, 2020
Public Version Number
1
DI Record Publish Date
May 12, 2020
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 | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |