SPEED Supercable

GUDID 75402950390097

Hespeler Orthodontics Limited

Orthodontic archwire
Primary Device ID75402950390097
NIH Device Record Key1af673a0-4976-4e9f-a62f-782b05df9a22
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED Supercable
Version Model Number75402950300096
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
GS175402950300096 [Primary]
GS175402950390097 [Unit of Use]

FDA Product Code

DZCWire, 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 Supercable]

7540295039009775402950300096
0754029590012607540295000192

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