Identity
- Trade Name
- SOFT PLUG® Silicone Punctum Plug FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- SOFT PLUG® Silicone Punctum Plug, Petite (0.6 mm) FDA UDI
- Model / Reference
- 6612-S, 6612, 6612-D FDA UDI
- Description
- SOFT PLUG® Silicone Punctum Plug, Petite (0.6 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845819000120 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
For medical professionals and patients, the SOFT PLUG Silicone Punctum Plug is a high-quality, sterile device designed to prevent tear outflow in dry eye patients. With its unique silicone material and precise punctal plug design, it ensures effective sealing and minimizes discomfort.
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 d035ca2d-7483-42ed-88eb-603250117aa0 34 fields · synced Jul 9, 2026