Duns Number:008162518
Device Description: Deep Gelpi Retr 12", 45 deg ang, 3" 1x1 blunt points, speedlock
Catalog Number
gS 40.8628
Brand Name
gSource
Version/Model Number
gS 40.8628
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
bd64330a-5f63-4d69-8752-b9af12138ee4
Public Version Date
September 07, 2022
Public Version Number
2
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 |