Identity
- Trade Name
- LINX Reflux Management System FDA UDI
- Generic Name
- Gastro-oesophageal antireflux prosthesis FDA UDI
- Model / Reference
- LXMC12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855106005325 FDA UDI
- PMA Number
- P100049 FDA UDI
- FDA Product Code
- LEI FDA UDI
- GMDN Term
- Gastro-oesophageal antireflux prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Gastro-oesophageal antireflux prosthesis
LINX Reflux Management System by Torax Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-oesophageal antireflux prosthesis.
- Uni-Patch — Cardinal Health 200, LLC · Class II
- Uni-Patch — Cardinalhealth · Class II
- LINX — Torax Medical, Inc. · Class III
- LINX — 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
Cleared under the same submission
P100049 also covers:
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
- Torax Medical, Inc.
Sources (1)
- FDA UDI 47e14128-600c-463a-90be-1b399b488905 33 fields · synced May 30, 2026