FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Essure
DI: 00888853030517
·
Model: ESS305-R1
·
Bayer Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Essure
- Primary DI
- 00888853030517
- Version / Model
- ESS305-R1
- Company Name
- Bayer Healthcare LLC
- Labeler DUNS
- 797856572
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-04
- Public Version
- 4
- Public Version Date
- 2020-04-08
- Public Version Status
- Update
- Public Device Record Key
- df300d8f-dfe4-4a48-b033-dc9733030b6e
- Distribution End Date
- 2018-12-31
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHS | Insert, Tubal Occlusion | Obstetrics/Gynecology | 884.5380 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888853030517 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P020014 | 012 |