FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516129617
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
5003CF.1
Device description
Irrigating Cystotome 25g X 22mm (7/8") Formed
Published
2023-08-23
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516129617PackageGS150In Commercial Distribution
00840516130118PackageGS1500In Commercial Distribution
00840516128221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516129617008405161296178405161296170840516129617
00840516130118008405161301188405161301180840516130118
00840516128221008405161282218405161282210840516128221

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
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

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