Subretinal Injection Cannula VS0220.25

GUDID B384VS0220251

Subretinal Injection Cannula for use with TPA

VORTEX SURGICAL, LLC

Vitrectomy fluid/gas handling handpiece/cannula

• Primary Device ID: B384VS0220251
• NIH Device Record Key: f5dee39a-1d10-4332-84ef-5003a7468638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Subretinal Injection Cannula
• Version Model Number: 25ga
• Catalog Number: VS0220.25
• Company DUNS: 080375891
• Company Name: VORTEX SURGICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B384VS0220251 [Primary]

FDA Product Code

• HMX: Cannula, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-03-09

Devices Manufactured by VORTEX SURGICAL, LLC

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• VS01102517 - 25ga Straight Laser Probe: 2020-02-06 25ga Straight Laser Probe
• VS01102719 - 27ga Straight Laser Probe: 2020-02-06 27ga Straight Laser Probe
• VS01202316 - 23ga Curved Laser Probe: 2020-02-06 23ga Curved Laser Probe
• VS01202518 - 25ga Curved Laser Probe: 2020-02-06 25ga Curved Laser Probe
• VS02251 - NANO SubRet Gateway Device: 2020-01-31 28ga Delivery Device for transcleral procedures
• B384VS05001 - I² Kit for intraocular injection: 2019-11-08 Intraocular Injection Kit - contains blade speculum and scleral marker
• B384VS05101 - I² Kit for intraocular injection: 2019-11-08 Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe