mi-eye 3

GUDID 00857356008231

mi-eye 3 needlescope, 95mm

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: 00857356008231
• NIH Device Record Key: c7bc5015-b961-45ad-944c-bd12dc133b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mi-eye 3
• Version Model Number: T300-095
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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	00857356008231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212556

FDA Product Code

• HRX: Arthroscope

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: 2023-11-17
• Device Publish Date: 2022-12-09

On-Brand Devices [mi-eye 3]

• 00857356008293: mi-eye 3 needlescope, 160mm
• 00857356008286: mi-eye 3 25° scope, 95mm with cannula
• 00857356008279: mi-eye 3 25° scope, 75mm with cannula
• 00857356008262: mi-eye 3 scope, 95mm with cannula
• 00857356008255: mi-eye 3 25 deg scope, 75mm with cannula
• 00857356008248: mi-eye 3 angled scope, 120mm
• 00857356008231: mi-eye 3 needlescope, 95mm