SPEED D-Wire - Stainless Steel

GUDID 07540295900072

Hespeler Orthodontics Limited

Orthodontic archwire
Primary Device ID07540295900072
NIH Device Record Keycf54e3c9-94e7-44f3-8a18-18bf5cf2a4ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED D-Wire - Stainless Steel
Version Model Number07540295000147
Company DUNS203297635
Company NameHespeler Orthodontics Limited
Device Count10
DM Exempttrue
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 Datetrue
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
GS107540295000147 [Primary]
GS107540295900072 [Unit of Use]
GS175402950300041 [Previous]

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 Date2024-08-19
Device Publish Date2024-08-09

On-Brand Devices [SPEED D-Wire - Stainless Steel]

7540295039004275402950300041
0754029590007207540295000147

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