Alcon

Primary DI
10380654262205
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065426220
Device description
Microsurgical Instrument IRR CYSTITOME 23GA REVERSE CUT DEEP-SET EYES
Published
2020-08-18
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
10380654262205PackageGS110In Commercial Distribution
00380654262208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065426220510380654262205
00380654262208003806542622083806542622080380654262208

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14
00380658552060Clareon TruPlusREYWT8REYWT8.2802026-05-14
00380658552077Clareon TruPlusREYWT8REYWT8.2852026-05-14
00380658552084Clareon TruPlusREYWT8REYWT8.2902026-05-14
00380658552091Clareon TruPlusREYWT8REYWT8.2952026-05-14
00380658552107Clareon TruPlusREYWT8REYWT8.3002026-05-14
00380658552114Clareon TruPlusREYWT8REYWT8.3102026-05-14
00380658552121Clareon TruPlusREYWT8REYWT8.3202026-05-14
00380658552138Clareon TruPlusREYWT8REYWT8.3302026-05-14
00380658552145Clareon TruPlusREYWT8REYWT8.3402026-05-14
00380658552152Clareon TruPlusREYWT9REYWT9.0602026-05-14
00380658552169Clareon TruPlusREYWT9REYWT9.0652026-05-14
00380658552176Clareon TruPlusREYWT9REYWT9.0702026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613046149MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2024-08-15
00840516141183Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2024-08-15
08052276012432Irrigating Cystotome Ang.45° 27Gx16mm AKTIVE SRLHNY2023-12-19
08052276012937Irrigating Cystotome Formed 27G x 16mmAKTIVE SRLHNY2023-12-19
08052276012968Irrigating Cystotome Ang.45° 25G x16 mm AKTIVE SRLHNY2023-12-19
00840516105345Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-10-10
00840516116600Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116617Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116624Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116631Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116648Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116655Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116662Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116679Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116686Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116693Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116709Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116716Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116754Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116761Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116778Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116785Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116792Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116808Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116815Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116822Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116839Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116846Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116853Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28
00840516116860Anodyne SurgicalPsi/Eye-Ko, Inc.HNY2023-08-28