Duns Number:966865636
Device Description: Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision te Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
Catalog Number
FG-8300-01-201
Brand Name
Eversense E3 Insertion Tools Kit
Version/Model Number
FG-8300-01-201
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"
Yes
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
P160048
Product Code
QHJ
Product Code Name
Sensor, Glucose, Implanted, Non-Adjunctive Use
Public Device Record Key
5f91607c-7c06-4f6e-88cf-1f3738c32b9a
Public Version Date
March 18, 2022
Public Version Number
1
DI Record Publish Date
March 10, 2022
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 33 |