Tensure 8002

GUDID M95580020

A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device

SENTREHEART, INC

Ligature loop tightener Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use Suture/ligature tightener, single-use

• Primary Device ID: M95580020
• NIH Device Record Key: 49e1a6e0-71a7-4c6d-a5de-0d09d8ad3233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tensure
• Version Model Number: 7 lb
• Catalog Number: 8002
• 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
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M95580020 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

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: 2020-05-06
• Device Publish Date: 2018-09-17

Devices Manufactured by SENTREHEART, INC

• M95520060 - EndoCATH: 2023-12-04 Large Occlusion Balloon Catheter
• M95580020 - Tensure: 2020-05-06A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device
• 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: 2020-02-06 A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected sc