Identity
- Trade Name
- SOFT PLUG® Silicone Punctum Plug FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- SOFT PLUG® Silicone, Economy Pack, Petite (0.6 mm) FDA UDI
- Model / Reference
- 6612-EP FDA UDI
- Description
- SOFT PLUG® Silicone, Economy Pack, Petite (0.6 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819000134 FDA UDI
- FDA Product Code
- LZU FDA UDI
- GMDN Term
- Lacrimal punctum plug 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
No
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
Radiation Sterilization FDA UDI
Category: Lacrimal punctum plug
A comprehensive device directory listing, providing detailed information about the Soft Plug Silicone Punctum Plug. The plug is designed to prevent tear outflow in dry eye patients and comes with a unique feature of being single-use.
Similar devices
Also classified as Lacrimal punctum plug.
- SuperFlex — Katena Products, Inc. · U
- Diamatrix — Diamatrix · U
- Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
- Comfortear Lacrisolve 180 Absorbable Punctum Plug — RIVERPOINT MEDICAL LLC · U
- Diamatrix — Diamatrix · U
- Stephens Instruments — KRISHNA IMPORTS INC · U
- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
- TearSaver® - 0.7 mm — FCI S A S FCI 20 22 · 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 |
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Manufacturer
- Manufacturer
- OASIS Medical, Inc.
Sources (1)
- FDA UDI a353820f-c5d4-4ba8-bc8c-732edcc42595 34 fields · synced Jul 9, 2026