Identity
- Trade Name
- Essure FDA UDI
- Generic Name
- Fallopian tube occlusion insert, non-biodegradable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ESS305-R1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888853030517 FDA UDI
- PMA Number
- P020014 FDA UDI
- FDA Product Code
- HHS FDA UDI
- GMDN Term
- Fallopian tube occlusion insert, non-biodegradable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 884.5380 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Essure by Bayer Healthcare — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Bayer Healthcare
Sources (1)
- FDA UDI df300d8f-dfe4-4a48-b033-dc9733030b6e 35 fields · synced May 31, 2026