Duns Number:008162518
Device Description: Hercules Cutter replacement TC inserts kit: inserts, screws, wrench for gS 83.7905
Catalog Number
gS 83.7906
Brand Name
gSource
Version/Model Number
gS 83.7906
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXZ
Product Code Name
Cutter, Wire
Public Device Record Key
a3f417ad-bbf7-4323-ba5f-5035d63df0f8
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
February 28, 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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |