Handpieces and Cannulae M4495

GUDID 25056030401392

Charles Flute Hnd/Cannula

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 25056030401392
• NIH Device Record Key: b3fb67a8-7fd3-4193-97f4-bcdf04a3bd45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handpieces and Cannulae
• Version Model Number: M4495-02/5
• Catalog Number: M4495
• Company DUNS: 504799313
• Company Name: STERIMEDIX LIMITED
• Device Count: 5
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15056030401395 [Primary]
GS1	25056030401392 [Unit of Use]

FDA Product Code

• MED: Sterilant, Medical Devices

Sterilization

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

[25056030401392]

Ethylene Oxide

[25056030401392]

Ethylene Oxide

[25056030401392]

Ethylene Oxide

[25056030401392]

Ethylene Oxide

[25056030401392]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [Handpieces and Cannulae]

• 25056030403020: Act/Pass Backflush 25g
• 25056030401392: Charles Flute Hnd/Cannula