FDA.report

Pelion 6 Month Plug

Primary DI
00810020085358
Brand
Pelion 6 Month Plug
Company
RIVERPOINT MEDICAL, LLC
Model
PPD0203
Device description
Canalicular Plug
Published
2020-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZUPlug, Punctum

Product Code Classifications

CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810020085355PackageGS110In Commercial Distribution
00810020085358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002008535510810020085355
00810020085358008100200853588100200853580810020085358

GMDN Terms

TermDefinition
Lacrimal punctum plugA sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
964053560
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840277405616LigaMend™ (Blue)112.0002026-03-19
00840277405623LigaMend™105.0002026-03-19
00840277405630Strut Suture103.0002026-03-19
00840277405715LigaMend™ Soft Button (Black)106.0002026-03-19
00840277405722LigaMend™ Soft Button (Blue)116.0002026-03-19
00840277411358No-Tie Button111.0002026-03-19
10810020085218HS FiberHS1652026-03-16
10840277411768HS FiberHS2412026-03-16
10840277411775HS FiberHS2422026-03-16
10840277411782HS FiberHS2432026-03-16
10840277411799HS FiberHS2442026-03-16
00840277411808HS FiberHS2452026-03-16
10840277411812Gold MarkerGM0453-20202026-03-11
00812444029673OrthoButton ALOBAL802026-03-03
00840277411068HS FiberDFX00182026-01-26
00840277411396HS FiberHS9032026-01-13
10840277411409HS FiberHS9042026-01-13
00840277410023ProZip Knotless ImplantCAT105012026-01-06
00840277410030ProZip Knotless ImplantCAT105022026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00385640089562Summit MedicalSummit Medical, Inc.LZU2025-12-29
00385640089579Summit MedicalSummit Medical, Inc.LZU2025-12-29
10840277405095Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405101Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405118Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405125Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
08800024300009Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300016Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300672Hello, eyesBio Optics Co., LtdLZU2024-07-30
00810061911944SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911951SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911968SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911975SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911982SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911913SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911920SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911937SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
23700773734768TearSaver® - 0.4 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734775TearSaver® - 0.5 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734782TearSaver® - 0.6 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734799TearSaver® - 0.7 mmFCI S A S FCI 20 22LZU2023-11-13
23700773734805TearSaver® - 0.8 mmFCI S A S FCI 20 22LZU2023-11-13
00850048647206Quintess Tear PoolEl Paso Medical, LLCLZU2023-08-11
00850048647213Quintess Tear PoolEl Paso Medical, LLCLZU2023-08-11
00845819000267SOFT PLUG® Extended Duration Plugs OASIS MEDICAL, INC.LZU2023-07-31
10845819000219SOFT PLUG® Extended Duration Plugs OASIS MEDICAL, INC.LZU2023-07-31
10845819005481SOFT PLUG® Extended Duration PlugsOASIS MEDICAL, INC.LZU2023-07-31
10845819000080SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30
10845819000103SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30
00845819000120SOFT PLUG® Silicone Punctum PlugOASIS MEDICAL, INC.LZU2023-06-30