Home GUDID 00348783012415 Premier Jackson Improved Short Tracheostomy Tube
Primary DI 00348783012415
Brand Premier Jackson Improved Short Tracheostomy Tube
Company PREMIER DENTAL PRODUCTS COMPANY
Model 8100041
Device description TT JACK IMP SHORT SS 5 W/ADPT
Published 2026-06-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FDA Enteroscope And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDA Enteroscope And Accessories Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00348783012415 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 00348783012415 00348783012415 348783012415 0348783012415
GMDN Terms# Term, Definition table Term Definition Surgical instrument/endoscope cleaning utensil, reusable A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 014789663 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 true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00860014745003 FUJIFILM Stiffening Wire (SW-2000) Fujifilm Healthcare Americas Corporation FDA 2025-12-18 04547410491715 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 04547410514056 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410491712 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410514053 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 10197106523643 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 50197106523641 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 10197106447185 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 50197106447183 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 10860006600805 Ancora Aspero Medical, Inc. FDA 2023-10-26 00847627004703 CD138 + Cyclin D1 BIOCARE MEDICAL LLC FDA 2023-06-21 04547410467284 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410324280 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410467260 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 14547410467281 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410463439 FUJIFILM FUJIFILM CORPORATION FDA 2022-01-30 04953170165801 HANGER ADAPTER SET OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165825 PROBE ARM SET A OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165849 PROBE ARM SET B OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165740 STOPPER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165757 WATER RESISTANT CAP OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165764 PROBE HANGER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 06934955960246 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical (ShenZhen) Co., Ltd. FDA 2020-12-25 00052569143735 HealthMart STRATEGIC SOURCING SERVICES LLC FDA 2020-07-31 10052569143732 HealthMart MCKESSON CORPORATION FDA 2020-07-31 00075289122811 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 70075289122810 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 04547410384536 FUJIFILM FUJIFILM CORPORATION FDA 2019-07-04 00811503033316 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27 10811503033306 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27