SureCUT 5001

GUDID M95550010

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.

SENTREHEART, INC

Suture cutter, single-use

• Primary Device ID: M95550010
• NIH Device Record Key: b336dc25-a4c8-4d47-b6d3-b6e206de321f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCUT
• Version Model Number: 5001
• Catalog Number: 5001
• Company DUNS: 068810802
• Company Name: SENTREHEART, 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

Customer Support Contacts

• Phone: 650-354-1200
• Email: info@sentreheart.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M95550010 [Primary]

FDA Product Code

• FZT: Cutter, Surgical

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: 2020-02-06
• Device Publish Date: 2018-09-17

Devices Manufactured by SENTREHEART, INC

• M95520060 - EndoCATH: 2023-12-04 Large Occlusion Balloon Catheter
• M95580020 - Tensure: 2020-05-06 A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascula
• M95550010 - SureCUT: 2020-02-06A 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.
• M95550010 - SureCUT: 2020-02-06 A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected sc