Identity
- Trade Name
- Medicon FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- Ti Mikro Mesh plate 165x140mm FDA UDI
- Model / Reference
- 68.86.84 FDA UDI
- Description
- Ti Mikro Mesh plate 165x140mm FDA UDI
Identifiers
- Catalog Number
- 68.86.84 FDA UDI
- Primary DI / UDI-DI
- 04046826485214 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Extra-gynaecological surgical mesh, metal
Medicon by Medicon eG. Chirurgiemechaniker-Genossenschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medicon eG. Chirurgiemechaniker-Genossenschaft
Sources (1)
- FDA UDI c72dc89b-2297-4b2c-bd01-81fb13740d29 35 fields · synced Jun 1, 2026