Identity
- Trade Name
- RITLENG+ PVP FDA UDI
- Generic Name
- Lacrimal tube FDA UDI
- Device Name
- An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone). FDA UDI
- Model / Reference
- S1.1495 FDA UDI
- Description
- An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760087127270 FDA UDI
- FDA Product Code
- OKS FDA UDI
- GMDN Term
- Lacrimal tube FDA UDI
Classification
- Device Class
- U 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lacrimal tube
Ritleng+ Pvp by Fci S A S Fci 20 22 — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal tube.
- STENTube — QUEST MEDICAL INC · U
- LACRIFLOW CL — Kaneka Corp. · U
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- Rumex — Rumex International Co. · Class II
- Rumex — Rumex International Co. · Class II
- LACRIFLOW — Kaneka Corp. · U
- STRADIS HEALTHCARE — STRADIS MEDICAL, LLC · Class II
- LACRIFLOW — Kaneka Corp. · U
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI 94832746-af6e-4d4c-b080-a613f4b875a4 33 fields · synced Jun 8, 2026