SPEED Tubular Supercable

GUDID 07540295900140

Hespeler Orthodontics Limited

Orthodontic archwire
Primary Device ID07540295900140
NIH Device Record Key0bbf0d83-0d36-4596-8c3d-0487a9b4ce5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEED Tubular Supercable
Version Model Number07540295000215
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
GS107540295000215 [Primary]
GS107540295900140 [Unit of Use]
GS175402950300119 [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 Tubular Supercable]

7540295039011075402950300119
0754029590014007540295000215

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