FDA.reportPublic FDA data

Lacrimal tube

Primary DI
03700773722129
Brand
Lacrimal tube
Company
FCI S A S FCI 20 22
Model
PVP SELF-THREADING MONOKA FAYET, BERNARD, RITLENG
Catalog number
S1.1821u
Device description
A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
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
OKSLacrimal Stents And Intubation Sets

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700773722129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700773722129037007737221293700773722129

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tubeAn implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.64Millimeter

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
00840516142142Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2024-03-14
13700773735096OPHTACATH® 2 mm Unilateral KitFCI S A S FCI 20 22OKS2023-12-28
13700773735102OPHTACATH® 2 mm Bilateral KitFCI S A S FCI 20 22OKS2023-12-28
13700773735119OPHTACATH® 3 mm Unilateral KitFCI S A S FCI 20 22OKS2023-12-28
13700773735126OPHTACATH® 3 mm Bilateral KitFCI S A S FCI 20 22OKS2023-12-28
00840516141978Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-12-21
00840516141992Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-12-21
00840516130828Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-08-24
00840516130873Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-08-24
00840516116464Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-08-02
00840516130842Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-08-02
00840516131467Anodyne SurgicalPsi/Eye-Ko, Inc.OKS2023-08-02
10845819000318Lacrimal lntubation SetOASIS MEDICAL, INC.OKS2023-06-30
00845819000359Lacrimal lntubation SetOASIS MEDICAL, INC.OKS2023-06-30
00845819000380Lacrimal lntubation SetOASIS MEDICAL, INC.OKS2023-06-30
00845819000397Lacrimal lntubation SetOASIS MEDICAL, INC.OKS2023-06-30
10845819000431Lacrimal lntubation SetOASIS MEDICAL, INC.OKS2023-06-30
10845819006099Disposable Instruments OASIS MEDICAL, INC.OKS2023-06-30
13760087126232RITLENG PROBE FCI S A S FCI 20 22OKS2021-05-30
M6332801870JEDMEDJEDMED INSTRUMENT COMPANYOKS2020-08-10
M6332801890JEDMEDJEDMED INSTRUMENT COMPANYOKS2020-08-10
M6332802000JEDMEDJEDMED INSTRUMENT COMPANYOKS2020-08-10
M63328A01840JEDMEDJEDMED INSTRUMENT COMPANYOKS2020-08-10
M63328A01850JEDMEDJEDMED INSTRUMENT COMPANYOKS2020-08-10
03700773722020Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25
03700773722037Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25
03700773722105Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25
03700773722112Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25
03700773722136Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25
03700773722143Lacrimal tubeFCI S A S FCI 20 22OKS2020-02-25