FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516145884
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
CB2011
Device description
Air Injection 18ga, Angled 5mm from bend to tip at 45 Degrees , 19mm Tube Length, 37mm Overall Length, including the hub, SS
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDMNeedle, Aspiration And Injection, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516145884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516145884008405161458848405161458840840516145884

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Ethylene Oxide
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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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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