Home GUDID 16973875280789 Makrite Industries Inc.
Primary DI 16973875280789
Brand Makrite Industries Inc.
Company Makrite Hubei Industrial Co., Ltd.
Model M663BT
Device description FDA cleared ASTM level 3 tie-on surgical pleated face mask, regular size.
Published 2023-07-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
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 16973875280789 Package GS1 40 In Commercial Distribution 06973875280782 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16973875280789 16973875280789 06973875280782 06973875280782 6973875280782
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 553815471 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16980077680071 AOK AOK TOOLING LIMITED FXX 2026-05-28 16980077680088 AOK AOK TOOLING LIMITED FXX 2026-05-28 16980077680095 AOK AOK TOOLING LIMITED FXX 2026-05-28 00681131106108 Equate WAL-MART STORES, INC. FXX 2026-02-25 00681131106092 Equate WAL-MART STORES, INC. FXX 2026-02-25 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