Duns Number:797856572
Device Description: Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched d Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a wound-down insert and a valved introducer.
Catalog Number
-
Brand Name
Essure
Version/Model Number
ESS305 (Kit)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P020014
Product Code
HHS
Product Code Name
Insert, Tubal Occlusion
Public Device Record Key
39d0e7b7-9ab5-4ada-b53e-95642279f2f6
Public Version Date
April 08, 2020
Public Version Number
4
DI Record Publish Date
September 04, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| 3 | A medical device with high risk that requires premarket approval | 5 |