FDA.reportPublic FDA data

Lacrimal punctum plug

Primary DI
03760087127140
Brand
Lacrimal punctum plug
Company
FCI S A S FCI 20 22
Model
PUNCTUM PLUGS - SLIM PACK (SLIM-MINI 0.4-SL) J. A.
Catalog number
S2.3324U
Device description
A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZUPlug, Punctum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760087127140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087127140037600871271403760087127140

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.43Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-932-4202orders@fci-ophthalmics.com

Regulatory Flags#

DUNS number
763408366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602026-02-17
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602021-05-30
23700773707472MACULORHEXIS FORCEPS 27 G S9.6012.272021-05-30
23700773707489END GRASPING FORCEPS 27 G S9.6013.272021-05-30
23700773707496TANO FORCEPS 27 G S9.6017.272021-05-30
23700773707502pince super grip 23GS9.6018.232021-05-30
23700773707519pince super grip 25GS9.6018.252021-05-30
23700773707526pince super grip 27GS9.6018.272021-05-30
23700773721041TANO POLISHER,20G S9.6016.202021-05-29
23700773721058TANO POLISHER,23G S9.6016.232021-05-29
23700773721065TANO POLISHER,25G S9.6016.252021-05-29
23700773721225DISPOSABLE TANO FORCEPS 23GS9.6017.232021-05-30
23700773721232DISPOSABLE TANO FORCEPS 25GS9.6017.252021-05-30
23700773721249DISPOSABLE SERRATED FORCEPS 23GS9.6011.232021-05-30
23700773721256DISPOSABLE SERRATED FORCEPS 25GS9.6011.252021-05-30
23700773721263DISPOSABLE MACULORHEXIS FORCEPS, 23GS9.6012.232021-05-30
23700773721270DISPOSABLE MACULORHEXIS FORCEPS, 25GS9.6012.252021-05-30
23700773721287DISPOSABLE END-GRASPING FORCEPS, 23GS9.6013.232021-05-30
23700773721294DISPOSABLE END-GRASPING FORCEPS, 25GS9.6013.252021-05-30
23700773721324DISPOSABLE VERTICAL SCISSORS, 23GS9.6015.232021-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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