Tensure 8002

GUDID M95580020

Ligature loop tightener

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

Device Issuing Agency	Device ID
HIBCC	M95580020 [Primary]

MDM	Instrument, Manual, Surgical, General Use

Steralize Prior To Use	false
Device Is Sterile	true

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

Mark Image Registration \| Serial	Company Trademark Application Date
TENSURE 98632148 not registered Live/Pending	Tensure Consulting, LLC 2024-07-03
TENSURE 98271153 not registered Live/Pending	Tensure Consulting, LLC 2023-11-15
TENSURE 98271116 not registered Live/Pending	Tensure Consulting, LLC 2023-11-15