SureCUT 5001

GUDID 00818354017595

A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.

ATRICURE, INC.

Pericardioscopic access cannula

• Primary Device ID: 00818354017595
• NIH Device Record Key: e728c89a-7011-47c2-a174-4c1a08d4c791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCUT
• Version Model Number: 5001
• Catalog Number: 5001
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00818354017595 [Primary]
HIBCC	M95550010 [Previous]

FDA Product Code

• FZT: Cutter, Surgical

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: 2020-01-07
• Device Publish Date: 2019-12-30

On-Brand Devices [SureCUT]

• 00818354017595: A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action.
• 30840143901786: SureCUT Suture Cutter
• 30840143903674: SureCUT Suture Cutter
• 30840143909614: SureCUT Suture Cutter