Thino Roth Bracket, .022, Mini Size, LL2

GUDID 86941673501640

Astar Orthodontics Inc.

Orthodontic bracket, metal
Primary Device ID86941673501640
NIH Device Record Key0a814c17-b3b4-4383-9ea3-5d8fb32020ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameThino Roth Bracket, .022, Mini Size, LL2
Version Model Number1212-032
Company DUNS547794613
Company NameAstar Orthodontics Inc.
Device Count8694167
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
GS106941673501644 [Primary]
GS186941673501640 [Unit of Use]

FDA Product Code

EJFBracket, Metal, 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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