Home GUDID 30840330703438 ProCure
Primary DI 30840330703438
Brand ProCure
Company Twin Med, LLC
Model PC622B
Catalog number PC622B
Device description Earloop Face Masks 3-Ply ASTM Level 1 - 50ea/bx 20bx/cs
Published 2023-08-28
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 30840330703438 Package GS1 20 In Commercial Distribution 10840330703434 Primary GS1 0 00840330703437 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 30840330703438 30840330703438 10840330703434 10840330703434 00840330703437 00840330703437 840330703437 0840330703437
GMDN Terms# Term, Definition table Term Definition Surgical/examination garment kit A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 3.75 Inch Length 6.9 Inch
Regulatory Flags# DUNS number 107071289 Device count 50 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 true 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 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