Home GUDID B6788232080 Tranquil-L™
Primary DI B6788232080
Brand Tranquil-L™
Company NEXUS SPINE, L.L.C.
Model 823208
Device description Dual Sided Rasp
Published 2022-02-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HTR Rasp
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTR Rasp General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B678823208 Direct Marking HIBCC 0 B6788232080 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone file/rasp, manual, reusable A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 028137605 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08806395408917 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408924 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408931 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408948 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408955 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408962 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408979 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408986 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395408993 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 08806395409006 Pulsar GS Medical Co., Ltd. HTR 2022-11-01 10381780503231 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2020-10-01 10381780507888 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-09-12 10381780393016 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-05-02 10381780280859 Integra® Spider™ Limted Wrist Fusion System Ascension Orthopedics, Inc. HTR 2018-04-13 10381780280866 Integra® Spider™ Limted Wrist Fusion System Ascension Orthopedics, Inc. HTR 2018-04-13 10381780467076 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-09 10381780467083 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-09 10381780467090 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-09 10381780189329 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-03 10381780192800 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-03 10381780192817 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780192824 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780192831 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780192848 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780192855 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780192862 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780193012 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-04-02 10381780461616 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-03-22 10381780212188 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-03-01 10381780212195 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HTR 2018-03-01