Formed Capsularhexis Cystotomes M3000G

GUDID 15056030400534

25g x 5/8" Cyst Fmd

STERIMEDIX LIMITED

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

• Primary Device ID: 15056030400534
• NIH Device Record Key: b1f6f63b-e720-4cba-9241-0dbb884f8b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Formed Capsularhexis Cystotomes
• Version Model Number: M3000G-02SP/10
• Catalog Number: M3000G
• Company DUNS: 504799313
• Company Name: STERIMEDIX LIMITED
• Device Count: 10
• 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	15056030400534 [Unit of Use]
GS1	25056030400531 [Primary]

FDA Product Code

• MED: Sterilant, Medical Devices

Sterilization

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

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

[15056030400534]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

Devices Manufactured by STERIMEDIX LIMITED

• 25056030400999 - Refractive Cannulae: 2025-04-02 25g x 7/8" Lin Lasik
• 25056030401019 - Vitreoretinal Cannulae: 2025-04-02 25g Silicone Brush
• 25056030401484 - Vitreoretinal Handpieces: 2025-04-02 Backflush/25g Soft Tip
• 35056030400996 - Vitreoretinal Cannulae: 2025-04-02 23g x 4mm VFI
• 35056030401009 - Vitreoretinal Cannulae: 2025-04-02 23g x 1 1/4" Asp Cann
• 55056030400969 - Hydrodissection Cannulae: 2025-02-25 30g x 7/8" Hydrodissector
• 15056030401746 - Bimanual I/A Systems: 2025-02-07 21g TW x 16m Bimanual
• 35056030400781 - Hydrodissection Cannulae: 2024-12-17 25g Tapered Hydro