Identity
- Trade Name
- Uni-Patch FDA UDI
- Generic Name
- Gastro-oesophageal antireflux prosthesis FDA UDI
- Device Name
- S Series Stimulating Electrodes,2804, Silver Carbon, Aloe Vera Gel FDA UDI
- Model / Reference
- EP85159 FDA UDI
- Description
- S Series Stimulating Electrodes,2804, Silver Carbon, Aloe Vera Gel FDA UDI
Identifiers
- Catalog Number
- EP85159 FDA UDI
- Primary DI / UDI-DI
- 10884521168374 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
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 2.75 Inch FDA UDI
Category: Gastro-oesophageal antireflux prosthesis
Uni-Patch by Cardinalhealth — 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
- Uni-Patch — Cardinal Health 200, LLC · Class II
- 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
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
- Cardinalhealth
Sources (1)
- FDA UDI 826d4105-d984-4f00-ab9d-730383b6700c 37 fields · synced May 30, 2026