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SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long, 2 plugs per pouch FDA UDI
- Model / Reference
- 6403, 6403-A FDA UDI
- Description
- SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long, 2 plugs per pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819000233 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 2.0 Millimeter FDA UDIOuter Diameter — 0.300 Millimeter FDA UDI
Category: Lacrimal punctum plug
SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long by OASIS Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 4bbe6b8e-565b-44ec-9bcc-968ebda330c3 36 fields · synced Jun 9, 2026