FDA.reportPublic FDA data

Alcon

Primary DI
00380654258201
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065425820
Device description
Microsurgical Instrument IRR. CYSTITOME 27GA FORMED-REVERSE CUTTING
Published
2020-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10380654258208PackageGS110In Commercial Distribution
00380654258201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065425820810380654258208
00380654258201003806542582013806542582010380654258201

GMDN Terms#

Term, Definition table
TermDefinition
Exploratory blunt needle, single-useA sterile, slender, hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

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