Essure

GUDID 10888853003051

Essure is a permanent Birth Control System. One Essure pouched disposable delivery system with a wound-down insert and a valved introducer. Two Pouched Delivery Systems are contained in the Essure Kit and are not sold separately.

Bayer Healthcare LLC

Fallopian tube occlusion insert

• Primary Device ID: 10888853003051
• NIH Device Record Key: 383aafe7-748b-432c-89a8-167c0762cc62
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Essure
• Version Model Number: ESS305
• Company DUNS: 797856572
• Company Name: Bayer Healthcare LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888853003051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020014

FDA Product Code

• HHS: Insert, Tubal Occlusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-08
• Device Publish Date: 2014-09-04

On-Brand Devices [Essure]

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