Convertible Buccal Tube Kit

GUDID 75402950800060

Hespeler Orthodontics Limited

Orthodontic bracket, metal
Primary Device ID75402950800060
NIH Device Record Key7e1d67a3-d0c5-4b21-ac2d-71d0cd057ede
Commercial Distribution Discontinuation2024-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameConvertible Buccal Tube Kit
Version Model Number75402950800060
Company DUNS203297635
Company NameHespeler Orthodontics Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS175402950800060 [Primary]

FDA Product Code

EJFBracket, Metal, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-12
Device Publish Date2022-12-09

On-Brand Devices [Convertible Buccal Tube Kit]

7540295080006075402950800060
0754029500039007540295000390

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.