FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516116464
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
8001
Device description
Lacrimal Intubation Set
Published
2023-08-02
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
00840516116471PrimaryGS10
00840516116464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516116471008405161164718405161164710840516116471
00840516116464008405161164648405161164640840516116464

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal procedural cannulaA hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
063763833
Device count
10
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
false
Expiration date on label
true
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
00840516145839Anodyne Surgical7007D2026-05-12
00840516145747Anodyne SurgicalRx404062026-04-17
00840516145761Anodyne SurgicalRx909052026-04-17
00840516145808Anodyne SurgicalCK20012026-04-17
00840516145815Anodyne SurgicalCK20022026-04-17
00840516142784Anodyne SurgicalAE03-2001-45062025-06-20
00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
00840516142647Anodyne Surgical9903-8FSP2025-06-12
00840516142654Anodyne Surgical9903-8FSP2025-06-12
00840516109893Anodyne Surgical8000-262023-06-21
00840516113326Anodyne Surgical8000-262023-06-21
00840516117454Anodyne Surgical8000-262023-08-30
00840516127842Anodyne Surgical0002F2023-08-23
00840516127859Anodyne Surgical00072023-08-23
00840516127866Anodyne Surgical0018B2023-08-23
00840516127873Anodyne Surgical0020-212023-08-23
00840516127880Anodyne Surgical0020.22023-08-23
00840516127897Anodyne Surgical1000-4.12023-08-23
00840516127903Anodyne Surgical1000-4.22023-08-23
00840516127910Anodyne Surgical1001-4.12023-08-23

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Primary DI, Brand, Company table
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13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
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13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET FCI S A S FCI 20 22OKS2026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732088STOPLOSS® JONES TUBE 4 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732095STOPLOSS® JONES TUBE 4 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732101STOPLOSS® JONES TUBE 4 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732118STOPLOSS® JONES TUBE 4 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732125STOPLOSS® JONES TUBE 4 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732132STOPLOSS® JONES TUBE 4 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732149STOPLOSS® JONES TUBE 4 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732156STOPLOSS® JONES TUBE 4 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732163STOPLOSS® JONES TUBE 4 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773735072STOPLOSS® JONES TUBE REMOVAL TOOL FCI S A S FCI 20 22OKS2026-04-20