Identity
- Trade Name
- Uni-Patch FDA UDI
- Generic Name
- Gastro-oesophageal antireflux prosthesis FDA UDI
- Device Name
- Uni-Patch™ S Series Stimulating Electrodes FDA UDI
- Model / Reference
- 2804 FDA UDI
- Description
- Uni-Patch™ S Series Stimulating Electrodes FDA UDI
Identifiers
- Catalog Number
- EP85159 FDA UDI
- Primary DI / UDI-DI
- 20192253018353 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Gastro-oesophageal antireflux prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastro-oesophageal antireflux prosthesis
Uni-Patch by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-oesophageal antireflux prosthesis.
- LINX — Torax Medical, Inc. · Class III
- LINX — Torax Medical, Inc. · Class III
- LINX Reflux Management System — Torax Medical, Inc. · Class III
- LINX — Torax Medical, Inc. · Class III
- ETHICON Linx Esophagus Sizing Tool — Torax Medical, Inc. · Class II
- LINX — Torax Medical, Inc. · Class III
- LINX — Torax Medical, Inc. · Class III
- Uni-Patch — Cardinalhealth · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI c0bb44e9-cbb6-4cf5-85a3-c53aa4d0a0f2 34 fields · synced Jun 8, 2026