Duns Number:008162518
Device Description: Inst Rack 13 1/2", holds 12 12 1/2" Cobb Elev gS 43.5410-43.5435, Curettes gS 51.8107-51.8 Inst Rack 13 1/2", holds 12 12 1/2" Cobb Elev gS 43.5410-43.5435, Curettes gS 51.8107-51.8160, alum, black
Catalog Number
gS 98.7020
Brand Name
gSource
Version/Model Number
gS 98.7020
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
3395a3b9-c491-4c6d-b669-773fd5671b5a
Public Version Date
August 18, 2022
Public Version Number
2
DI Record Publish Date
March 04, 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 |