Home GUDID H65811259599 Henry Schein
Primary DI H65811259599
Brand Henry Schein
Company HENRY SCHEIN, INC.
Model 1125959
Catalog number 1125959
Device description Ceraket .022 Kit U/L 5x5 Roth HKS
Published 2020-06-24
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 NJM Bracket, ceramic, orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NJM Bracket, Ceramic, Orthodontic Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H65811259591 Primary HIBCC 0 H65811259599 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthodontic bracket, ceramic A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
Regulatory Flags# DUNS number 012430880 Device count 20 DM exempt false Premarket exempt false HCT/P false Kit true 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07908611210067 PROMO KIT ICERAM-P ROTH 0.022 ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA NJM 2024-04-16 08800046016025 VAR-18-301 GNI Co.,Ltd NJM 2022-12-14 08800046016032 VAR-18-331 GNI Co.,Ltd NJM 2022-12-14 08800046016049 VAR-18-051 GNI Co.,Ltd NJM 2022-12-14 08800046016056 VAR-18-501 GNI Co.,Ltd NJM 2022-12-14 08800046016063 VAR-18-551 GNI Co.,Ltd NJM 2022-12-14 08800046016070 VAR-18-053 GNI Co.,Ltd NJM 2022-12-14 08800046016087 VAR-18-503 GNI Co.,Ltd NJM 2022-12-14 08800046016094 VAR-18-553 GNI Co.,Ltd NJM 2022-12-14 08800046016100 VAR-22-031 GNI Co.,Ltd NJM 2022-12-14 08800046016117 VAR-22-301 GNI Co.,Ltd NJM 2022-12-14 08800046016124 VAR-22-331 GNI Co.,Ltd NJM 2022-12-14 08800046016131 VAR-22-051 GNI Co.,Ltd NJM 2022-12-14 08800046016148 VAR-22-501 GNI Co.,Ltd NJM 2022-12-14 08800046016155 VAR-22-551 GNI Co.,Ltd NJM 2022-12-14 08800046016162 VAR-22-053 GNI Co.,Ltd NJM 2022-12-14 08800046016179 VAR-22-503 GNI Co.,Ltd NJM 2022-12-14 08800046016193 VAM-18-031 GNI Co.,Ltd NJM 2022-12-14 08800046016209 VAM-18-301 GNI Co.,Ltd NJM 2022-12-14 08800046016216 VAM-18-331 GNI Co.,Ltd NJM 2022-12-14 08800046016223 VAM-18-051 GNI Co.,Ltd NJM 2022-12-14 08800046016230 VAM-18-501 GNI Co.,Ltd NJM 2022-12-14 08800046016247 VAM-18-551 GNI Co.,Ltd NJM 2022-12-14 08800046016254 VAM-18-053 GNI Co.,Ltd NJM 2022-12-14 08800046016261 VAM-18-503 GNI Co.,Ltd NJM 2022-12-14 08800046016278 VAM-18-553 GNI Co.,Ltd NJM 2022-12-14 08800046016285 VAM-22-031 GNI Co.,Ltd NJM 2022-12-14 08800046016292 VAM-22-301 GNI Co.,Ltd NJM 2022-12-14 08800046016308 VAM-22-331 GNI Co.,Ltd NJM 2022-12-14 08800046016315 VAM-22-051 GNI Co.,Ltd NJM 2022-12-14