SPEED Split Stop

GUDID 75402950490032

Hespeler Orthodontics Limited

Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock
Primary Device ID75402950490032
NIH Device Record Key92dc718b-f93b-41b2-8497-505da5fbe2d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED Split Stop
Version Model Number75402950400031
Company DUNS203297635
Company NameHespeler Orthodontics Limited
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS175402950400031 [Primary]
GS175402950490032 [Unit of Use]

FDA Product Code

ECNClamp, Wire, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-18
Device Publish Date2022-11-10

On-Brand Devices [SPEED Split Stop]

7540295049003275402950400031
7540295049011775402950400116

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