Backflush Aspiration Handpieces M4489

GUDID 45056030401341

Backflush Handle

STERIMEDIX LIMITED

Ophthalmic surgical irrigation/infusion/aspiration handle, single-use

• Primary Device ID: 45056030401341
• NIH Device Record Key: a661ddca-f678-457f-bf54-6b49c6a70ce2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Backflush Aspiration Handpieces
• Version Model Number: M4489-02/5
• Catalog Number: M4489
• 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	15056030401340 [Primary]
GS1	45056030401341 [Unit of Use]

FDA Product Code

• MED: Sterilant, Medical Devices

Sterilization

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

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

Ethylene Oxide

[45056030401341]

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 [Backflush Aspiration Handpieces]

• 25056030401354: Active / Passive
• 45056030401341: Backflush Handle