Essure

GUDID 20888853003058

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.

Bayer Healthcare LLC

Fallopian tube occlusion insert
Primary Device ID20888853003058
NIH Device Record Key39d0e7b7-9ab5-4ada-b53e-95642279f2f6
Commercial Distribution Discontinuation2018-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEssure
Version Model NumberESS305 (Kit)
Company DUNS797856572
Company NameBayer Healthcare LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888853003058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHSInsert, Tubal Occlusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-08
Device Publish Date2014-09-04

On-Brand Devices [Essure]

20888853003058Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposa
10888853003051Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with
00888853030517Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched d

Trademark Results [Essure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESSURE
ESSURE
76333607 2719977 Live/Registered
BAYER HEALTHCARE LLC
2001-11-02
ESSURE
ESSURE
76263888 2725358 Live/Registered
BAYER HEALTHCARE LLC
2001-05-29

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