FDA.reportPublic FDA data

N/A

Primary DI
10818255011026
Brand
N/A
Company
MICROVISION, INC.
Model
N/A
Catalog number
5243
Device description
Disposable Two-Step Trocar System, 23Ga. (3 Trocar Cannula Inserters with Pre-Loaded Self-Sealing Trocar Cannula & 1 Infusion Line)
Published
2018-04-04
Public version status
Update
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
30818255011020PackageGS15In Commercial Distribution
10818255011026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081825501102030818255011020
1081825501102610818255011026

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.655Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00caution
Special Storage Condition, Specify00keep away from direct sunlight
Special Storage Condition, Specify00keep dry

Regulatory Flags#

DUNS number
013486803
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818255011194NAStyle 50354032017-12-22
10818255011200NAStyle 50454042017-12-22
10818255011217NAStyle 50554052017-12-22
10818255011224NAStyle 50654072017-12-22
10818255011231NAStyle 50754082017-12-22
10818255011323NAStyle 27754312017-12-22
10818255011330NAStyle 27954322017-12-22
10818255011378NAStyle 27654382017-12-22
10818255011385NAStyle 28654402017-12-22
10818255011392NAStyle 28754412017-12-22
10818255011415NAStyle 24054452017-12-22
10818255011422NAStyle 27054462017-12-22
10818255011439NAStyle 7054472017-12-22
10818255011446NAStyle 4854482017-12-22
10818255011453NAStyle 4054492017-12-22
10818255011460NAStyle 4254502017-12-22
10818255011491NAStyle 10654542017-12-22
10818255011521NAStyle 11254602017-12-22
30818255011198NAStyle 50354032017-12-22
30818255011204NAStyle 50454042017-12-22

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
00380650004680UNITYAlcon Laboratories, Inc.NGY2024-11-19
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