Duns Number:040729840
Device Description: FINOCHIETTO STYLE RETRACTOR BLADE
Catalog Number
-
Brand Name
FINOCHIETTO SMALL RETRACTOR BLADE
Version/Model Number
416-862
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2018
Issuing Agency
In HIBCC
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
K152400
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
3cbb2875-9116-4864-852a-bc834329396c
Public Version Date
May 10, 2021
Public Version Number
8
DI Record Publish Date
August 26, 2016
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 |