TenSURE FG-0017

GUDID 30840143901915

Suture knot-tying device

Primary Device ID	30840143901915
NIH Device Record Key	0108dfb7-b808-40c6-9618-1a64620610c3
Commercial Distribution Status	In Commercial Distribution
Brand Name	TenSURE
Version Model Number	80-02
Catalog Number	FG-0017
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 Issuing Agency	Device ID
GS1	00818354017618 [Previous]
GS1	10840143901911 [Primary]
GS1	30840143901915 [Package] Contains: 10840143901911 Package: box [1 Units] In Commercial Distribution
GS1	50840143901896 [Package] Package: case [10 Units] In Commercial Distribution

FZT	Cutter, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

00818354017618	A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature lo
30840143901915	TenSURE Suture Tightener
30840143903728	TenSURE Suture Tightener
30840143909683	TenSURE Suture Tightener

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