MK-500500

GUDID 30810003221958

MicroKeratome Blades, ACS/ALK. Each blade is laser inspected and calibrated. 10/bx

MICROSPECIALITIES, INC.

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• Primary Device ID: 30810003221958
• NIH Device Record Key: 04275804-aa8c-41c5-b934-c2d27b791d1a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MK-500500
• Catalog Number: MK-500500
• Company DUNS: 013469890
• Company Name: MICROSPECIALITIES, INC.
• 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

Customer Support Contacts

• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx
• Phone: 203-874-1832
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810003221954 [Primary]
GS1	30810003221958 [Package]; Contains: 10810003221954; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020482

FDA Product Code

• HNO: Keratome, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-12
• Device Publish Date: 2019-01-03

Devices Manufactured by MICROSPECIALITIES, INC.

• 30810003221040 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, Plano. Have the ultimate control of corneal flap thickness while us
• 30810003221057 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 10. Have the ultimate control of corneal flap thickness while
• 30810003221064 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 20. Have the ultimate control of corneal flap thickness while
• 30810003221071 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 30. Have the ultimate control of corneal flap thickness while
• 30810003221088 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, minus 40. Have the ultimate control of corneal flap thickness while
• 30810003221095 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, plus 10. Have the ultimate control of corneal flap thickness while
• 30810003221101 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated HANSATOME Compatible, PLUS 20. Have the ultimate control of corneal flap thickness while
• 30810003221118 - NA: 2024-02-12 MicroKeratome Blades, Laser Calibrated XP, Plano. Have the ultimate control of corneal flap thickness while using a single head