FDA.reportPublic FDA data

UNITY

Primary DI
00380650004680
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380650004680
Catalog number
8065000468
Device description
27GA Infusion Cannula (includes TMD) – for use with 4mm/6 mm ES
Published
2024-11-19
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

Product Codes#

Code, Name table
CodeName
NGYCannula, Trocar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGYCannula, Trocar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20380650004684PackageGS112In Commercial Distribution
00380650004680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038065000468420380650004684
00380650004680003806500046803806500046800380650004680

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380650003492ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003508ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003553ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003560ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003584ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003591ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650003959UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650003966UNITYAlcon Laboratories, Inc.NGY2025-04-08
00380650004673ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003499ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003505ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003550ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003567ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003581ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003598ALCONAlcon Laboratories, Inc.NGY2025-04-08
10380650003956UNITYAlcon Laboratories, Inc.NGY2025-04-08
10380650003963UNITYAlcon Laboratories, Inc.NGY2025-04-08
20380650004677ALCONAlcon Laboratories, Inc.NGY2025-04-08
00380650004703AlconAlcon Laboratories, Inc.NGY2024-11-19
20380650004684UNITYAlcon Laboratories, Inc.NGY2024-11-19
20380650004707AlconAlcon Laboratories, Inc.NGY2024-11-19
00380650003522ALCONAlcon Laboratories, Inc.NGY2024-07-02
00380650003539ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003529ALCONAlcon Laboratories, Inc.NGY2024-07-02
10380650003536ALCONAlcon Laboratories, Inc.NGY2024-07-02
0871787203493523G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
0871787203494225G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
0871787203495927G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203493223G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21
1871787203494925G High Flow infusion lineD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NGY2024-02-21