Home GUDID 07899439238381 ADITEK
Primary DI 07899439238381
Brand ADITEK
Company Aditek do Brasil Ltda
Model 05.04.0318
Device description 10 Kits 5x5 BioMax 022 Roth Maxillary Hk 3 w/100
Published 2023-09-06
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 Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07899439238381 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07899439238381 07899439238381 7899439238381
GMDN Terms# Term, Definition table Term Definition Orthodontic bracket, metal A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. 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 900761396 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 false Sterilization required before use false Other Devices From This Company#