FDA.reportPublic FDA data

MANI Infusion Cannula

Primary DI
74546951405747
Brand
MANI Infusion Cannula
Company
MANI, INC.
Model
MIC27S Infusion Cannula 27G S
Device description
MANI Trocar Kit
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
14546951405745PrimaryGS10
74546951405747Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1454695140574514546951405745
7454695140574774546951405747

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690622428
Device count
6
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
14546951639997MANI MICRO FORCEPSSquare 25G 360 Grip 33mm2026-09-18
14546951640009MANI MICRO FORCEPSRound 25G 360 Grip 33mm2026-09-18
14546951640016MANI MICRO FORCEPSILM 25G 360 Grip 33mm2026-09-18
14546951640023MANI MICRO FORCEPSSquare 27G 360 Grip 33mm2026-09-18
14546951640030MANI MICRO FORCEPSRound 27G 360 Grip 33mm2026-09-18
14546951640047MANI MICRO FORCEPSILM 27G 360 Grip 33mm2026-09-18
14546951640054MANI MICRO FORCEPSEXFine 27G 360 Grip 33mm2026-09-18
14546951640061MANI MICRO FORCEPSSquare 25G 360 Grip 28mm2026-09-18
14546951640078MANI MICRO FORCEPSRound 25G 360 Grip 28mm2026-09-18
14546951640085MANI MICRO FORCEPSILM 25G 360 Grip 28mm2026-09-18
14546951640092MANI MICRO FORCEPSSquare 27G 360 Grip 28mm2026-09-18
14546951640108MANI MICRO FORCEPSRound 27G 360 Grip 28mm2026-09-18
14546951640115MANI MICRO FORCEPSILM 27G 360 Grip 28mm2026-09-18
14546951640122MANI MICRO FORCEPSEXFine 27G 360 Grip 28mm2026-09-18
14546951616721MANI Ophthalmic KnifeMSL24CH Slit-Angled 2.4mm CH2026-07-23
14546951627383MANI Ophthalmic KnifeMSL22CH Slit-Angled 2.2mm CH2026-07-23
14546951627390MANI Ophthalmic KnifeMSL27CH Slit-Angled 2.75mm CH2026-07-23
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08

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