Home GUDID D1251192 Premium Plus
Primary DI D1251192
Brand Premium Plus
Company Premium Plus (Dongguan) Limited
Model 119
Device description Disposable Barrier Sleeves
Published 2026-05-22
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 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 D1251198 Package HIBCC 4 In Commercial Distribution D1251192 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Digital imaging cassette A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.
Regulatory Flags# DUNS number 541637603 Device count 1 DM exempt true 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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