MicroStaar SFC-45

GUDID 00840311344796

Intraocular Lens Insertion Cartridge

STAAR SURGICAL COMPANY

Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge

• Primary Device ID: 00840311344796
• NIH Device Record Key: 3e027598-486d-4fc2-a806-5be5a2b5b71c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroStaar
• Version Model Number: SFC-45
• Catalog Number: SFC-45
• Company DUNS: 054751110
• Company Name: STAAR SURGICAL COMPANY
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311344796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152357

FDA Product Code

• MSS: Folders And Injectors, Intraocular Lens (Iol)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [MicroStaar]

• 00840311300020: Reusable Injector
• 00840311300013: Reusable Injector
• 10840311300027: Reusable Injector
• 10840311300010: Reusable Injector
• 00840311344802: Foam tip plunger
• 00840311344796: Intraocular Lens Insertion Cartridge