mi-eye 2

GUDID 00857356008026

MI-EYE 2 SYSTEM, MI-ULTRA, EN

TRICE MEDICAL, INC.

Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use Rigid optical arthroscope, single-use

• Primary Device ID: 00857356008026
• NIH Device Record Key: 44ad2848-e92c-4777-ac81-906fef6ebd54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mi-eye 2
• Version Model Number: T200-010
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00857356008026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162475

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-17
• Device Publish Date: 2022-12-09

On-Brand Devices [mi-eye 2]

• 00857356008118: TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM
• 00857356008026: MI-EYE 2 SYSTEM, MI-ULTRA, EN