Home GUDID D773334HH10451 Health-Tec/DHP Hedstrom Files
Primary DI D773334HH10451
Brand Health-Tec/DHP Hedstrom Files
Company Dental Health Products Inc
Model 334-HH1045
Catalog number 334-HH1045
Device description Health-Tec/DHP Hedstrom Files 45-21mm White 6/pkg
Published 2022-10-12
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 EKS File, Pulp Canal, Endodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKS File, Pulp Canal, Endodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D773334HH10451 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Manual endodontic file/rasp, reusable A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 623191194 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true 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 false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D7735901000721 DHP/Health-Tec Sterilization Tape 590-100072 590-100072 2023-03-24 D7735901000821 DHP/Health-Tec Sterilization Tape 590-100082 590-100082 2023-03-24 D7736001000320 DHP/Health-Tec Sterilization Pouches 600-100032 600-100032 2023-03-23 D7736001000420 DHP/Health-Tec Sterilization Pouches 600-100042 600-100042 2023-03-23 D7736001000520 DHP/Health-Tec Sterilization Pouches 600-100052 600-100052 2023-03-23 D7736001000620 DHP/Health-Tec Sterilization Pouches 600-100062 600-100062 2023-03-23 D7736001000720 DHP/Health-Tec Sterilization Pouches 600-100072 600-100072 2023-03-23 D7736001000820 DHP/Health-Tec Sterilization Pouches 600-100082 600-100082 2023-03-23 D7736001000920 DHP/Health-Tec Sterilization Pouches 600-100092 600-100092 2023-03-23 D7736001001020 DHP/Health-Tec Sterilization Pouches 600-100102 600-100102 2023-03-23 D7736001001120 DHP/Health-Tec Sterilization Pouches 600-100112 600-100112 2023-03-23 D773970100010 Health-Tec/DHP Disposable Prophy Angles 970-10001 970-10001 2022-11-28 D773970100020 Health-Tec/DHP Disposable Prophy Angles 970-10002 970-10002 2022-11-28 D7739705220140 Health-Tec/DHP Disposable Prophy Angles 970-522014 970-522014 2022-11-28 D773970522140 Health-Tec/DHP Disposable Prophy Angles 970-522114 970-522114 2022-11-28 D7739705224140 Health-Tec/DHP Disposable Prophy Angles 970-522414 970-522414 2022-11-28 D7739705225140 Health-Tec/DHP Disposable Prophy Angles 970-522514 970-522514 2022-11-28 D773930100060 Health-Tec/DHP PSP Barrier Envelopes 930-10006 930-10006 2022-11-14 D773930HTBWT0 Health-Tec/DHP Bite Wing Tabs 930-HTBWT 930-HTBWT 2022-11-14 D773800100020 Health-Tec/DHP Matrix Bands 800-10002 800-10002 2022-11-10
Other Devices Sharing Product Codes#