FDA.reportPublic FDA data

Lacrimal dilator, single-use

Primary DI
33760087120555
Brand
Lacrimal dilator, single-use
Company
FCI S A S FCI 20 22
Model
DISPOSABLE PUNCTUM DILATOR AND PLUG INSERTER
Catalog number
S1.3090U
Device description
A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760087120554PrimaryGS10
33760087120555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087120554037600871205543760087120554
3376008712055533760087120555

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, single-useA sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length133Millimeter

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
3
DM exempt
false
Premarket exempt
true
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
13700773729644IRIS RETRACTOR 5 HOOKSS9.50152026-07-09
13700773731906TearSaver® - 0.4 mmS2.38422026-07-09
13700773731913TearSaver® - 0.5 mmS2.38522026-07-09
13700773736994TearSaver® - 0.8 mmS2.38822026-07-09
13700773737007Snug plugS2.4002U2026-07-09
23700773728705PRELOADED PERFORATED PLUG PVP - J.A. BERNARDS1.35122026-07-09
23700773728712PRELOADED MINI PERFORATED PLUG PVP - J.A. BERNARDS1.35222026-07-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995319830V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319847V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319878V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319885V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319892V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319908V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319915V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319922V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319939V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319946V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319953V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319960V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319977V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319984V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00190776421823MillenniumAvalign Technologies, Inc.HNW2026-06-24
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKA1 Medical GmbHHNW2026-06-09
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27