FDA.reportPublic FDA data

Lacrimal punctum plug

Primary DI
23760087120572
Brand
Lacrimal punctum plug
Company
FCI S A S FCI 20 22
Model
PRE-LOADED PVP MINI PERFORATED PLUG J.A. BERNARD,
Catalog number
S1.3522u
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
true
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
03760087120578PrimaryGS10
23760087120572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087120578037600871205783760087120578
2376008712057223760087120572

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 Diameter0.7Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
763408366
Device count
2
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
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM S1.73212026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM S1.73222026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM S1.74092026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM S1.74102026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM S1.74112026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM S1.74122026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM S1.74132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640072403Quintess®Summit Medical, Inc.LZU2026-05-13
00385640072410Quintess®Summit Medical, Inc.LZU2026-05-13
00385640089562Summit MedicalSummit Medical, Inc.LZU2025-12-29
00385640089579Summit MedicalSummit Medical, Inc.LZU2025-12-29
00840277405098Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405104Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405111Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405128Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
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
00810061911197SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911203SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911210SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911227SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911234SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911241SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911258SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911265SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
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