27ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex

GUDID 00840096213140

27ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex Connector

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 00840096213140
• NIH Device Record Key: 1008e132-05b0-4163-91dd-85b315b1154d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex
• Version Model Number: V6300-27AR
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840096213140 [Unit of Use]
GS1	10840096213147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121187

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-06
• Device Publish Date: 2020-09-28

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