Stainless Steel Archwire, Euro II, .018, Upper

GUDID 06941673534918

Astar Orthodontics Inc.

Orthodontic wire
Primary Device ID06941673534918
NIH Device Record Keyb2bde192-1c2c-4e02-bf3c-593a2cc3ec68
Commercial Distribution StatusIn Commercial Distribution
Brand NameStainless Steel Archwire, Euro II, .018, Upper
Version Model Number6161-1800-II
Company DUNS547794613
Company NameAstar Orthodontics Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106941673534918 [Primary]
GS186941673534914 [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 Date2024-01-08
Device Publish Date2023-12-31

Devices Manufactured by Astar Orthodontics Inc.

86941673501459 - Thino Roth Bracket, .022, Mini Size, UL12024-01-08
86941673501466 - Thino Roth Bracket, .022, Mini Size, UL22024-01-08
86941673501473 - Thino Roth Bracket, .022 Mini, UL3, w/hk at distal2024-01-08
86941673501480 - Thino Roth Bracket, .022 Mini, UL4, w/o hook2024-01-08
86941673501497 - Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial2024-01-08
86941673501503 - Thino Roth Bracket, .022 Mini, UL4, w/hk at distal2024-01-08
86941673501510 - Thino Roth Bracket, .022 Mini, UL5, w/o hook2024-01-08
86941673501527 - Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial2024-01-08

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