Home GUDID 00816419020771 iSmile
Primary DI 00816419020771
Brand iSmile
Company Ismile Dental Products, Inc.
Model 45-1536
Catalog number 45-1536
Device description Earloop Mask Level 3 White
Published 2024-09-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name FXX Mask, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FXX Mask, Surgical General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816419020771 Primary GS1 0 20816419020775 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816419020771 00816419020771 816419020771 0816419020771 20816419020775 20816419020775
GMDN Terms# Term, Definition table Term Definition Surgical/medical face mask, non-antimicrobial, single-use A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Regulatory Flags# DUNS number 016765988 Device count 40 Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809755250171 KP Protective Face Mask KP trading Co., Ltd. FXX 2026-02-19 10097604555514 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2025-07-28 10371347011606 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011613 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10371347011620 Advance Dental Products The Atlanta Dental Supply Company FXX 2024-03-01 10097604543320 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604553022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604563229 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10097604573624 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2024-01-19 10195327560522 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. FXX 2023-12-21 10097604537022 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10097604538128 Tronex International, Inc. TRONEX INTERNATIONAL, INC. FXX 2023-12-11 10304040169022 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169039 Essentials HENRY SCHEIN, INC. FXX 2023-07-05 10304040169046 Criterion HENRY SCHEIN, INC. FXX 2023-07-05 10304040165253 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040165260 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168483 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168490 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168582 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168612 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168629 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168643 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168650 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168926 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168933 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10304040168940 Criterion HENRY SCHEIN, INC. FXX 2023-06-26 10087701434423 Good Neighbor Shepard Medical Products, Inc. FXX 2023-01-06 10096295122296 Leader Shepard Medical Products, Inc. FXX 2023-01-06 10096295137382 Leader Shepard Medical Products, Inc. FXX 2023-01-06