AccessGUDID - DEVICE: Essure (00888853030517)

GUDID

Device Identifier (DI) Information

Brand Name: Essure
Version or Model: ESS305-R1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Bayer Healthcare LLC

Primary DI Number: 00888853030517
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 797856572 *Terms of Use

Device Description: Essure is a permanent Birth Control System. One Essure Replacement Kit containing one pouched disposable delivery system with a wound-down insert and a valved introducer.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32678	Fallopian tube occlusion insert	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HHS	Insert, Tubal Occlusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020014	012

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df300d8f-dfe4-4a48-b033-dc9733030b6e
Public Version Date: April 08, 2020
Public Version Number: 4
DI Record Publish Date: September 04, 2014