FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516105390
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
5003ASR
Device description
Irrigating Cystotome 25g X 16mm (5/8"), small radius
Published
2023-06-14
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840516109220PrimaryGS10
00840516112725PrimaryGS10
00840516105390Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516109220008405161092208405161092200840516109220
00840516112725008405161127258405161127250840516112725
00840516105390008405161053908405161053900840516105390

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
00841668145968BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145982BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145999BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146002BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146019BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146071BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146095BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146132BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146149BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146170BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146194BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146200BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146231BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146248BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00757770416783Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770429943Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770433896Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00194613002251MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002275MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002305MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002329MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002336MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002343MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002459MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613052317MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103576MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103620MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103859MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104245MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104672MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01