Identity
- Trade Name
- ETHICON Linx Esophagus Sizing Tool FDA UDI
- Generic Name
- Gastro-oesophageal antireflux prosthesis FDA UDI
- Device Name
- ETHICON Linx Esophagus Sizing Tool FDA UDI
- Model / Reference
- LST FDA UDI
- Description
- ETHICON Linx Esophagus Sizing Tool FDA UDI
Identifiers
- Catalog Number
- LST FDA UDI
- Primary DI / UDI-DI
- 10855106005438 FDA UDI
- 510(k) Number
- K201035 FDA UDI
- FDA Product Code
- QJN FDA UDI
- GMDN Term
- Gastro-oesophageal antireflux prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5360 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
Category: Gastro-oesophageal antireflux prosthesis
ETHICON Linx Esophagus Sizing Tool by Torax Medical, Inc. — Class II — 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 Reflux Management System — Torax Medical, Inc. · Class III
- LINX — Torax Medical, Inc. · Class III
- 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
- Torax Medical, Inc.
Sources (1)
- FDA UDI 408ba3f4-d3da-41a1-9f63-78a75d0d6aff 36 fields · synced Jun 6, 2026