FDA.reportPublic FDA data

25ga Edge Advantage ILM Elevator

Primary DI
B384VS0300255
Brand
25ga Edge Advantage ILM Elevator
Company
VORTEX SURGICAL, LLC
Model
VS0300.25
Catalog number
VS0300.25
Device description
25ga ILM Elevator
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B384VS0300255PackageHIBCC5In Commercial Distribution
B384VS0300251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ophthalmic hook, single-useA hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6367784350info@vortexsurgical.com

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
false
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
true
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
B384VS020025525ga Soft Tip CannulaVS0200.25VS0200.252016-11-30
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

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