Bimanual I/A Systems M5538

GUDID 25056030401811

25g x 5/8" Bimanual

STERIMEDIX LIMITED

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

• Primary Device ID: 25056030401811
• NIH Device Record Key: 96002cb1-1cfc-419b-a59f-93f951218282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bimanual I/A Systems
• Version Model Number: M5538-02/5
• Catalog Number: M5538
• 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: false
• 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	15056030401814 [Primary]
GS1	25056030401811 [Unit of Use]

FDA Product Code

• MED: Sterilant, Medical Devices

Sterilization

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

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

[25056030401811]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-15
• Device Publish Date: 2024-10-07

On-Brand Devices [Bimanual I/A Systems]

• 35056030401740: 21g TW x 16m Bimanual
• 15056030401746: 21g TW x 16m Bimanual
• 15056030401791: 23g Twin Pack Irr/Asp
• 25056030401811: 25g x 5/8" Bimanual
• 35056030401788: Twin Pack Irr/Asp
• 25056030401576: 21g TW x 16mm Bimanual