FDA.reportPublic FDA data

25ga Soft Tip Cannula

Primary DI
B384VS0200255
Brand
25ga Soft Tip Cannula
Company
VORTEX SURGICAL, LLC
Model
VS0200.25
Catalog number
VS0200.25
Device description
25ga Soft Tip Cannula
Published
2016-11-30
Public version status
Update
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B384VS0200255PackageHIBCC5In Commercial Distribution
B384VS0200251PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080375891
Device count
1
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
false
Expiration date on label
false
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
B384VS020023523ga Soft Tip CannulaVS0200.23VS0200.232016-11-30
B384VS011020A520ga Straight Laser Probe - Alcon compatibleVS0110.20AVS0110.20A2016-09-24
B384VS011023A523ga Straight Laser Probe - Alcon CompatibleVS0110.23AVS0110.25A2016-09-24
B384VS011025A525ga Straight Laser Probe - Alcon CompatibleVS0110.25AVS0110.25A2016-09-24
B384VS012020A520ga Curved Laser Probe - Alcon CompatibleVS0120.20AVS0120.20A2016-09-24
B384VS012025A525ga Curved Laser Probe - Alcon CompatibleVS120.25AVS120.25A2016-09-24
B384VS012027A527ga Curved Laser Probe - Alcon CompatibleVS0120.27AVS0120.27A2016-09-24
B384012027I527ga Curved Laser Probe - Iridex CompatibleVS0120.27IVS0120.27I2016-09-24
B384VS013020A520ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.20AVS0130.20A2016-09-24
B384VS013023A523ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.23AVS0130.23A2016-09-24
B384VS013023I523ga Flexible Tapered Laser Probe - Iridex CompatiVS0130.23IVS0130.23I2016-09-24
B384VS013025A525ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.25AVS0130.25A2016-09-24
B384VS013025I525ga Flexible Tapered Laser Probe - Iridex CompatiVS0130.25IVS0130.25I2016-09-24
B384VS014020A520ga Bending Laser Probe - Alcon CompatibleVS0140.20AVS0140.20A2016-09-24
B384VS014023A523ga Bending Laser Probe - Alcon CompatibleVS0140.23AVS0140.23A2016-09-24
B384VS014023I523ga Bending Laser Probe - Iridex CompatibleVS0140.23IVS0140.23I2016-09-24
B384VS014025A525ga Bending Laser Probe - Alcon CompatibleVS0140.25AVS0140.25A2016-09-24
B384VS014025I525ga Bending Laser Probe - Iridex CompatibleVS0140.25IVS0140.25I2016-09-24
B384VS030023523ga Edge Advantage ILM ElevatorVS0300.23VS300.232016-11-30
B384VS030025525ga Edge Advantage ILM ElevatorVS0300.25VS0300.252016-11-30

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