Duns Number:899060826
Device Description: Straight 1x2 Kocher hemostat 16cm
Catalog Number
-
Brand Name
Quinelato
Version/Model Number
QF.414.16
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
9bd53a50-abf5-4d06-9ff3-8d61f589eae1
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
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 | 545 |