Duns Number:008162518
Device Description: gRetractor, Harrington 12 1/2", 62mm blade, silicone hdl, blue
Catalog Number
gS 36.3532
Brand Name
gSource
Version/Model Number
gS 36.3532
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
GAD
Product Code Name
Retractor
Public Device Record Key
5d1493bf-bb46-4fe0-95ac-e724b87d5267
Public Version Date
December 18, 2019
Public Version Number
1
DI Record Publish Date
December 10, 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 |