FDA.reportPublic FDA data

25G PASSIVE ASP HP W/SOFT TIP 12B

Primary DI
24058935005461
Brand
25G PASSIVE ASP HP W/SOFT TIP 12B
Company
Bausch & Lomb GmbH
Model
SUJ02
Catalog number
SUJ02
Device description
Single Use Medical Device for Ophthalmic Surgery
Published
2023-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058935005467PrimaryGS10
24058935005461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058935005467040589350054674058935005467
2405893500546124058935005461

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy fluid/gas handling handpiece/cannulaA sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344609518
Device count
12
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058935012779Fogla Trifacet SpatulaE04792025-10-24
04058935012786Fogla Pointed DissectorE04802025-10-24
04058935012809Guide ClaymanE05422025-10-24
04058935012816Hook Lens And Iris SinskeyE05452025-10-24
04058935012823Hook Lens OgawaE05692025-10-24
04058935012830Chopper Spatula NichaminE0570 N2025-10-24
04058935012847Hook Lens Manipulator LesterE05712025-10-24
04058935012854Hook Lens Insertion FenzlE05722025-10-24
04058935012861Chopper Phaco Left NagaharaE0578 L2025-10-25
04058935012878Chopper Phaco Right NagaharaE0578 R2025-10-26
04058935012885Hook Lens MaloneyE05792025-10-26
04058935012892Chopper Ambidextrous SeibelE05902025-10-26
04058935012908Hook Muscle StevensE06002025-10-26
04058935012915Manipulator Nucleus DrysdaleE06292025-10-26
04058935012922Brody Multipurpose ManipulatorE06362025-10-26
04058935012939Spatula Phaco KochE07122025-10-26
04058935012946Snapper Lens ChopperE07292025-10-26
04058935012953Spatula JohnsonE07302025-10-26
04058935012960Chopper Quick-Chop Braga MeleE07562025-10-26
04058935012977Forceps Fixation Curved MoodyE15532025-10-26

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Primary DI, Brand, Company table
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G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
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G412CA14210MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14220MR PHACOCrestpoint Management LimitedHMX2025-05-27
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G412CA14250MR PHACOCrestpoint Management LimitedHMX2025-05-27
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G412CA14270MR PHACOCrestpoint Management LimitedHMX2025-05-27