FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516130828
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
8001
Device description
Lacrimal Intubation Set
Published
2023-08-24
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
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
00840516130828PackageGS150In Commercial Distribution
00840516130835PackageGS1500In Commercial Distribution
00840516130811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516130828008405161308288405161308280840516130828
00840516130835008405161308358405161308350840516130835
00840516130811008405161308118405161308110840516130811

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal intubation setA collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Radiation Sterilization
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)428-5628info@anodynesurgical.com

Regulatory Flags#

DUNS number
063763833
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
00840516142654Anodyne Surgical9903-8FSP2025-06-12
00840516142685Anodyne SurgicalCB30012025-02-28
00840516142661Anodyne SurgicalCI10052025-01-30
00840516142678Anodyne SurgicalCI10092025-01-30
00840516142579Anodyne SurgicalCG10052025-01-10
00840516142562Anodyne SurgicalCG10042024-12-12
00840516142555Anodyne SurgicalAFK-00072024-10-25
00840516142463Anodyne SurgicalCL50012024-09-30
00840516142470Anodyne SurgicalCX10012024-09-30
00840516142487Anodyne SurgicalCB20102024-09-30
00840516142494Anodyne SurgicalCB20092024-09-30
00840516142500Anodyne SurgicalCQ10022024-09-30
00840516141190Anodyne Surgical5004BFT2024-08-15
00840516142401Anodyne SurgicalCG10032024-08-02
00840516141923Anodyne SurgicalAFK-00012024-04-26
00840516141930Anodyne SurgicalAFK-00022024-04-26
00840516142005Anodyne SurgicalAFK-00032024-04-26
00840516142159Anodyne SurgicalAFK-00042024-04-26
00840516142166Anodyne SurgicalAFK-00052024-04-26

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
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
03700773722129Lacrimal 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