Duns Number:008162518
Device Description: Finochietto Rib Spreader Child alum blades 1 1/5" [30mm] x 1" [28mm] with 5 1/2" [143mm] o Finochietto Rib Spreader Child alum blades 1 1/5" [30mm] x 1" [28mm] with 5 1/2" [143mm] opening
Catalog Number
gS 40.9036
Brand Name
gSource
Version/Model Number
gS 40.9036
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
FFO
Product Code Name
Retractor, Self-Retaining
Public Device Record Key
945fe24c-5a55-4ba8-adb3-f45d7d98a0db
Public Version Date
September 30, 2022
Public Version Number
3
DI Record Publish Date
December 23, 2019
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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |