Duns Number:044606982
Device Description: ECHELON CONTOUR GST RELOAD GREEN
Catalog Number
GCR40G
Brand Name
ECHELON
Version/Model Number
GCR40G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDW
Product Code Name
Staple, implantable
Public Device Record Key
7ddddc2e-e8d7-44e3-98dd-302e4bc03dcd
Public Version Date
December 14, 2021
Public Version Number
1
DI Record Publish Date
December 06, 2021
Package DI Number
30705036027472
Quantity per Package
84
Contains DI Package
10705036027478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |