Home GUDID 20840128600058 TULA
Primary DI 20840128600058
Brand TULA
Company Smith & Nephew, Inc.
Model ESREG
Catalog number ESREG
Device description TULA EARSET SPARE - REGULAR
Published 2020-03-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name QJA Tympanostomy tube delivery product with drug
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QJA Tympanostomy Tube Delivery Product With Drug Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20840128600058 Package GS1 1 In Commercial Distribution 00840128600054 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20840128600058 20840128600058 00840128600054 00840128600054 840128600054 0840128600054
GMDN Terms# Term, Definition table Term Definition Drug-delivery iontophoresis system, single-use An assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a disposable, battery-powered, current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a single-use device.
Regulatory Flags# DUNS number 109903521 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true 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 00885556833933 Salto Talaris Total Ankle Prosthesis MJU952T MJU952T 2022-12-22 00885556833940 Salto Talaris Total Ankle Prosthesis MJU953T MJU953T 2022-12-22 00885556833957 Salto Talaris Total Ankle Prosthesis MJV219T MJV219T 2022-12-22 00885556833964 Salto Talaris Total Ankle Prosthesis MJV220T MJV220T 2022-12-22 00885556833971 Salto Talaris Total Ankle Prosthesis MJV221T MJV221T 2022-12-22 00885556833988 Salto Talaris Total Ankle Prosthesis MJV229T MJV229T 2022-12-22 00885556834237 Silicone Toe System CGT-205T CGT-205T 2022-12-22 00885556834251 Silicone Toe System CGT-305T CGT-305T 2022-12-22 00885556834299 Silicone Toe System CGT-505T CGT-505T 2022-12-22 00885556835029 Ti6 Internal Fixation System DS1007 DS1007 2022-12-22 00885556835203 Surgical Instruments FS-1006 FS-1006 2022-12-22 00885556836187 Ti6 Internal Fixation System TH3018 TH3018 2022-12-22 00885556837856 Total Foot System 2 2204250 2204250 2022-12-22 00885556838785 Total Foot System 2 2823027 2823027 2022-12-21 00885556841631 XT Revision Ankle Replacement System MJU984T MJU984T 2022-12-21 00885556841778 XT Revision Ankle Replacement System MJV222T MJV222T 2022-12-21 00885556841785 XT Revision Ankle Replacement System MJV223T MJV223T 2022-12-21 00885556854921 Freedom Wrist Arthroplasty System 348047 348047 2022-12-22 00885556856680 Surgical Instruments EXT-200-00 EXT-200-00 2022-12-22 00885556860168 Titan Modular Shoulder System 2.5 DRL-0923-047-001 DRL-0923-047-001 2022-12-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556817667 TULA Smith & Nephew, Inc. QJA 2024-04-29 00885556817674 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817742 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817759 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817766 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817773 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817780 TULA Smith & Nephew, Inc. QJA 2024-04-23 00885556817797 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817685 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817692 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817708 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817715 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817722 TULA Smith & Nephew, Inc. QJA 2024-04-23 20885556817739 TULA Smith & Nephew, Inc. QJA 2024-04-23 00840128600160 TULA Smith & Nephew, Inc. QJA 2020-03-27 00840128600054 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600078 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600085 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600092 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600108 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600115 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600122 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600207 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600016 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600023 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600030 TULA Smith & Nephew, Inc. QJA 2020-03-25 00840128600047 TULA Smith & Nephew, Inc. QJA 2020-03-25 20840128600072 TULA Smith & Nephew, Inc. QJA 2020-03-25 20840128600089 TULA Smith & Nephew, Inc. QJA 2020-03-25 20840128600096 TULA Smith & Nephew, Inc. QJA 2020-03-25