Duns Number:078352849
Device Description: Hemostat Kelly curved 14cm/5.50" - A hand-held, manual, open-surgery instrument designed t Hemostat Kelly curved 14cm/5.50" - A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels). It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. This is a reusable device intended to be sterilized prior to use.
Catalog Number
Kelly Hemostat Curved
Brand Name
Kelly Hemostat Curved
Version/Model Number
Kelly Hemostat Curved
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
daa39ffd-cd97-4d3b-a8e0-bae97cecf608
Public Version Date
December 10, 2021
Public Version Number
1
DI Record Publish Date
December 02, 2021
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |