Essure

Primary DI
20888853003058
Brand
Essure
Company
Bayer Healthcare LLC
Model
ESS305 (Kit)
Device description
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.
Published
2014-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHSInsert, Tubal Occlusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHSTranscervical Contraceptive Tubal Occlusion DeviceObstetrics/Gynecology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020014012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020014012ESSURE SYSTEMBayer Pharma AG2002-11-04HHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888853003058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088885300305820888853003058

GMDN Terms#

Term, Definition table
TermDefinition
Fallopian tube occlusion insertA small, sterile, implantable device that is implanted into the uterine end of the fallopian tubes (one device in each tube) to functions as a contraceptive through the obstruction of the natural fallopian tube passage. It typically consists of a micro insert with a stainless steel inner coil, a nickel-titanium alloy (Nitinol) "elastic" outer coil, and polyethylene (PE) fibres loaded into a delivery device. Upon placement and delivery, during a hysteroscopy, the device expands and anchors to the varied diameters and shapes of the fallopian tube and results in tubal occlusion by the PE fibres eliciting a tissue in-growth, this preventing the passage of ova.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797856572
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888853030517EssureESS305-R12014-09-04
10888853003051EssureESS3052014-09-04
00616258003832AVX105039-0011050392014-10-09
00616258003849XVG105042-0011050422014-10-09
00616258003856SPIROFLEX VG106608-0011066082014-10-07
00616258003887SPIROFLEX106553-0011065532014-10-09
00616258003894XMI105041-0011050412014-10-07
00616258003917SOLENT PROXI109676-0011096762014-10-09
00616258003924SOLENT OMNI 109681-0011096812014-10-07
00616258003955FETCH 2109400-0011094002014-10-09
00616258005089SOLENT DISTA111303-0011113032014-10-09
00616258005096DISTAFLEX111304-0011113042014-10-07
00616258005164JETWIRE011525-0010115252015-02-27
00311017405307Dr. Scholl's 16121712016-09-01
00311017405321Dr. Scholl's 16121712016-09-01
00311017405345Dr. Scholl's 16121712016-09-01
00011017576983Dr. Scholl's 16121712018-02-12
10311017405304Dr. Scholl's 16121712016-09-01
00016500574057Aleve16135382017-09-01
00325866565044Aleve 16135382016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888853030517EssureBayer Healthcare LLCHHS2014-09-04
10888853003051EssureBayer Healthcare LLCHHS2014-09-04