TrabEx Pro 600050-01

GUDID 00844685009381

The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.

MICROSURGICAL TECHNOLOGY, INC.

Ophthalmic knife, single-use

• Primary Device ID: 00844685009381
• NIH Device Record Key: 2ba175b4-c8b4-450a-be0a-40eb78eafabe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrabEx Pro
• Version Model Number: 600050-01
• Catalog Number: 600050-01
• Company DUNS: 097824130
• Company Name: MICROSURGICAL TECHNOLOGY, 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: 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	00844685009381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213173

FDA Product Code

• MRH: Pump, Infusion, Ophthalmic

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: 2022-09-30
• Device Publish Date: 2022-09-22

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