FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516121734
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
9010SB
Device description
Extrusion Cannula 20g X 32mm, straight, blunt
Published
2023-08-30
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516121734PackageGS150In Commercial Distribution
00840516125619PackageGS1500In Commercial Distribution
00840516117874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516121734008405161217348405161217340840516121734
00840516125619008405161256198405161256190840516125619
00840516117874008405161178748405161178740840516117874

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;Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
063763833
Device count
1
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
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
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

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