Home GUDID 30840143909683 TenSURE
Primary DI 30840143909683
Brand TenSURE
Company ATRICURE, INC.
Model 80-02
Catalog number FG-0017-02
Device description TenSURE Suture Tightener
Published 2023-04-06
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30840143909683 Package GS1 1 In Commercial Distribution 50840143909687 Package GS1 10 In Commercial Distribution 10840143909696 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30840143909683 30840143909683 50840143909687 50840143909687 10840143909696 10840143909696
GMDN Terms# Term, Definition table Term Definition Suture knot-tying device A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry place
Regulatory Flags# DUNS number 006133784 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10840143912832 Cannula with Guide CSK-6131 CSK-6131-3 2026-05-31 10840143902666 cryoICE® System A001150 A001150-1 2026-05-27 10840143902673 cryoICE® System A001150 A001150-2 2026-05-27 10840143902680 cryoICE® System A001150 A001150-3 2026-05-27 10840143902697 cryoICE® System A001150 A001150-4 2026-05-27 10840143902703 cryoICE® System A001150 A001150-5 2026-05-27 10840143902710 cryoICE® System A001150 A001150-6 2026-05-27 10840143902727 cryoICE® System A001150 A001150-7 2026-05-27 10840143902734 cryoICE® System A001150 A001150-8 2026-05-27 30840143904343 cryoICE® System CMF1 A001359 2026-05-27 30840143912164 AtriCure® cryoICE® BOX ACM1 A000896-5 2026-05-27 30840143913703 Multifunctional Ablation Generator MAG A001372 2026-05-27 10840143913761 Isolator Synergy™ OSL2 A000432-12 2026-05-12 10840143913440 AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion System PRO135 A000824 2026-04-28 10840143913457 AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion System PRO140 A000825 2026-04-28 10840143913464 AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion System PRO145 A000826 2026-04-28 10840143913471 AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion System PRO150 A000827 2026-04-28 10840143913488 AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion System PRO235 A000965 2026-04-28 10840143913495 AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion System PRO240 A000966 2026-04-28 10840143913501 AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion System PRO245 A000967 2026-04-28
Other Devices Sharing Product Codes# 
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