Home GUDID D943N78286 Power Dental U.S.A., Inc.
Primary DI D943N78286
Brand Power Dental U.S.A., Inc.
Company Power Dental U.S.A. Inc.
Model N7828-6
Catalog number N7828-6
Device description CASSETTE 80x75x45mm
Published 2021-07-13
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 false Product Codes# Code, Name table Code Name FSM TRAY, SURGICAL, INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D943N78286 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sterilization/disinfection container, reusable A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081305064 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false 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 true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D943ORCAA0 Power Dental USA ORCAA ORCAA 2021-06-20 D94367350 Power Dental USA 6735 6735 2021-06-20 D94367380 Power Dental USA 6738 6738 2021-06-20 D94367390 Power Dental USA 6739 6739 2021-06-20 D94367410 Power Dental USA 6741 6741 2021-06-20 D94367430 Power Dental USA 6743 6743 2021-06-20 D9431007E0 Power Dental USA 1007E 1007E 2021-07-13 D94315240 Power Dental USA 1524 1524 2021-06-20 D94335090 Power Dental USA 3509 3509 2021-06-20 D9434826XAS0 Power Dental USA 4826XAS 4826XAS 2021-07-13 D94362100 Power Dental USA 6210 6210 2021-06-20 D94364470 Power Dental USA 6447 6447 2022-01-08 D943813050 Power Dental USA 8130-5 8130-5 2021-07-13 D943DCAM0 Power Dental USA DCAM DCAM 2021-07-13 D943DCAM30 Power Dental USA DCAM3 DCAM3 2021-07-13 D943KIM10 Power Dental USA KIM-1 KIM-1 2022-07-12 D943KIM120 Power Dental USA KIM-12 KIM-12 2022-07-12 D943KIM20 Power Dental USA KIM-2 KIM-2 2022-07-12 D943KIM240 Power Dental USA KIM-24 KIM-24 2021-07-13 D943KIM30 Power Dental USA KIM-3 KIM-3 2022-07-12
Other Devices Sharing Product Codes# 
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