FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516126760
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
9020-25
Device description
High Viscosity Fluid Cannula 25g
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516127293PrimaryGS10
00840516127828PrimaryGS10
00840516126760Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516127293008405161272938405161272930840516127293
00840516127828008405161278288405161278280840516127828
00840516126760008405161267608405161267600840516126760

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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
100
DM exempt
false
Premarket exempt
true
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
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
00810163790577Diamatrix Ltd.DiamatrixHMX2026-05-26
00841668145906BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145913BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145920BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145937BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145944BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145951BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146040BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146057BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146088BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146101BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146118BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146125BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146156BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146163BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146187BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146217BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146224BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146255BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145487BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146286BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146293BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146309BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146316BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146323BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146330BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146347BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146354BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146361BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146378BLINKKATENA PRODUCTS, INC.HMX2026-03-23