SPEED Buccal Tube Sample Kit

GUDID 75402950800077

Hespeler Orthodontics Limited

Orthodontic bracket, metal
Primary Device ID75402950800077
NIH Device Record Keyf925285c-d999-431e-9ed6-bb4f77183772
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED Buccal Tube Sample Kit
Version Model Number75402950800077
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
GS175402950800077 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-27
Device Publish Date2023-02-17

On-Brand Devices [SPEED Buccal Tube Sample Kit]

7540295019010975402950100108
7540295080007775402950800077

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