Home GUDID D8381588 Premium Plus
Primary DI D8381588
Brand Premium Plus
Company Premium Plus International Limited
Model 158
Device description Disposable Barrier Sleeves
Published 2017-07-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name PEM Dental Barriers And Sleeves
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEM Dental Barriers And Sleeves General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D8381588 Package HIBCC 10 In Commercial Distribution D8381582 Primary HIBCC 0 D8381580 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Instrument/equipment drape, single-use, non-sterile A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.
Regulatory Flags# DUNS number 668367758 Device count 500 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B9764488001 OptiClear Sleeves Minitube AB PEM 2026-02-13 B9764488041 OptiClear Sleeves Minitube AB PEM 2026-02-13 B9764488061 OptiClear Sleeves Minitube AB PEM 2026-02-13 10618125192301 Carina TIDI PRODUCTS, LLC PEM 2025-09-22 00618125187126 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125187133 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125187140 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125188710 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125188727 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125188734 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125189953 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125190171 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 00618125190188 VALO TIDI PRODUCTS, LLC PEM 2025-08-29 20665973031815 Unipack Dukal LLC PEM 2025-03-20 20665973031822 Unipack Dukal LLC PEM 2025-03-20 20665973031839 Unipack Dukal LLC PEM 2025-03-20 10304040186722 Acclean HENRY SCHEIN, INC. PEM 2024-10-02 00816577024581 Young Infinity Young Innovations, Inc. PEM 2024-09-30 00816577024604 Denticator YOUNG DENTAL MANUFACTURING I, LLC PEM 2024-09-30 00816577024611 Denticator YOUNG DENTAL MANUFACTURING I, LLC PEM 2024-09-30 00816577024628 Denticator YOUNG DENTAL MANUFACTURING I, LLC PEM 2024-09-30 00816577024635 Denticator YOUNG DENTAL MANUFACTURING I, LLC PEM 2024-09-30 20850061028024 Dental Basics Dental Basics Inc. PEM 2024-05-08 10371347011941 Advance Dental Products The Atlanta Dental Supply Company PEM 2024-01-04 10371347011958 Advance Dental Products The Atlanta Dental Supply Company PEM 2024-01-04 00816419021617 iSmile Ismile Dental Products, Inc. PEM 2023-06-21 00816419021624 iSmile Ismile Dental Products, Inc. PEM 2023-06-21 00816419021853 iSmile Ismile Dental Products, Inc. PEM 2023-06-21 00816419021860 iSmile Ismile Dental Products, Inc. PEM 2023-06-21 00816419021877 iSmile Ismile Dental Products, Inc. PEM 2023-06-21