25ga Endo-Ocular Probes-Flexible Illuminated

GUDID 00817489024508

Box of 10, 25ga Endo-Ocular Probes-Flexible Illuminated

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 00817489024508
• NIH Device Record Key: e64962d9-2caa-40c1-9758-a5533b651920
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25ga Endo-Ocular Probes-Flexible Illuminated
• Version Model Number: XLEND25ILLCA
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 1
• 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	00817489024508 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-22

On-Brand Devices [25ga Endo-Ocular Probes-Flexible Illuminated]

• 00817489024515: Box of 10, 25ga Endo-Ocular Probes-Flexible Illuminated
• 00817489024508: Box of 10, 25ga Endo-Ocular Probes-Flexible Illuminated