SPEED Crimpable Stop

GUDID 75402950490025

Hespeler Orthodontics Limited

Orthodontic lock
Primary Device ID75402950490025
NIH Device Record Key4e5cdc95-0595-40e7-91d3-e1323fa74a8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED Crimpable Stop
Version Model Number75402950400024
Company DUNS203297635
Company NameHespeler Orthodontics Limited
Device Count10
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
GS175402950400024 [Primary]
GS175402950490025 [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 Crimpable Stop]

7540295049002575402950400024
0754029590015707540295000222

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