G&H ORTHODONTICS®

GUDID 10190886015308

AGILITY® CERAMIC MBT .018 L1/2 -6°T 0°A BRACKETS

G & H WIRE COMPANY, INC.

Orthodontic bracket, ceramic
Primary Device ID10190886015308
NIH Device Record Key220f2d51-d6c8-4ccf-8dd7-388f5b0b4bee
Commercial Distribution StatusIn Commercial Distribution
Brand NameG&H ORTHODONTICS®
Version Model Number126-L1-8U-V
Company DUNS831465641
Company NameG & H WIRE COMPANY, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone+1-317-346-6655
Emailorders@ghortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190886015301 [Unit of Use]
GS110190886015308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-19
Device Publish Date2019-12-11

On-Brand Devices [G&H ORTHODONTICS®]

10190886015605AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
10190886015599AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
10190886015582AGILITY® CERAMIC MBT .018 UR4/5 HK -7°T 0°A BRACKETS
10190886015575AGILITY® CERAMIC MBT .018 UL4/5 HK -7°T 0°A BRACKETS
10190886015568AGILITY® CERAMIC MBT .022 UR4/5 HK -7°T 0°A BRACKETS
10190886015551AGILITY® CERAMIC MBT .022 UL4/5 HK -7°T 0°A BRACKETS
10190886015544AGILITY® CERAMIC MBT .018 UR3 HK -7°T +8°A BRACKETS
10190886015537AGILITY® CERAMIC MBT .018 UL3 HK -7°T +8°A BRACKETS
10190886015520AGILITY® CERAMIC MBT .022 UR3 HK -7°T +8°A BRACKETS
10190886015513AGILITY® CERAMIC MBT .022 UL3 HK -7°T +8°A BRACKETS
10190886015506AGILITY® CERAMIC MBT .018 UR2 +10°T +8°A BRACKETS
10190886015490AGILITY® CERAMIC MBT .018 UL2 +10°T +8°A BRACKETS
10190886015483AGILITY® CERAMIC MBT .022 UR2 +10°T +8°A BRACKETS
10190886015476AGILITY® CERAMIC MBT .022 UL2 +10°T +8°A BRACKETS
10190886015469AGILITY® CERAMIC MBT .018 UR1 +17°T +4°A BRACKETS
10190886015452AGILITY® CERAMIC MBT .018 UL1 +17°T +4°A BRACKETS
10190886015445AGILITY® CERAMIC MBT .022 UR1 +17°T +4°A BRACKETS
10190886015438AGILITY® CERAMIC MBT .022 UL1 +17°T +4°A BRACKETS
10190886015421AGILITY® CERAMIC MBT .018 LR5 HK -17°T 0°A BRACKETS
10190886015414AGILITY® CERAMIC MBT .018 LL5 HK -17°T 0°A BRACKETS
10190886015407AGILITY® CERAMIC MBT .022 LR5 HK -17°T 0°A BRACKETS
10190886015391AGILITY® CERAMIC MBT .022 LL5 HK -17°T 0°A BRACKETS
10190886015384AGILITY® CERAMIC MBT .018 LR4 HK -12°T 0°A BRACKETS
10190886015377AGILITY® CERAMIC MBT .018 LL4 HK -12°T 0°A BRACKETS
10190886015360AGILITY® CERAMIC MBT .022 LR4 HK -12°T 0°A BRACKETS
10190886015353AGILITY® CERAMIC MBT .022 LL4 HK -12°T 0°A BRACKETS
10190886015346AGILITY® CERAMIC MBT .018 LR3 HK -6°T +3°A BRACKETS
10190886015339AGILITY® CERAMIC MBT .018 LL3 HK -6°T +3°A BRACKETS
10190886015322AGILITY® CERAMIC MBT .022 LR3 HK -6°T +3°A BRACKETS
10190886015315AGILITY® CERAMIC MBT .022 LL3 HK -6°T +3°A BRACKETS
10190886015308AGILITY® CERAMIC MBT .018 L1/2 -6°T 0°A BRACKETS
10190886015292AGILITY® CERAMIC MBT .022 L1/2 -6°T 0°A BRACKETS
10190886015285AGILITY® CERAMIC BRACKET SYSTEM ROTH PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
10190886015278AGILITY® CERAMIC BRACKET SYSTEM ROTH PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
10190886015261AGILITY® CERAMIC ROTH .018 UR4/5 HK -7°T 0°A BRACKETS
10190886015254AGILITY® CERAMIC ROTH .018 UL4/5 HK -7°T 0°A BRACKETS
10190886015247AGILITY® CERAMIC ROTH .022 UR4/5 HK -7°T 0°A BRACKETS
10190886015230AGILITY® CERAMIC ROTH .022 UL4/5 HK -7°T 0°A BRACKETS
10190886015223AGILITY® CERAMIC ROTH .018 UR3 HK 0°T +11°A 4°R BRACKETS
10190886015216AGILITY® CERAMIC ROTH .018 UL3 HK 0°T +11°A 4°R BRACKETS
10190886015209AGILITY® CERAMIC ROTH .022 UR3 HK 0°T +11°A 4°R BRACKETS
10190886015193AGILITY® CERAMIC ROTH .022 UL3 HK 0°T +11°A 4°R BRACKETS
10190886015186AGILITY® CERAMIC ROTH .018 UR2 +8°T +9°A BRACKETS
10190886015179AGILITY® CERAMIC ROTH .018 UL2 +8°T +9°A BRACKETS
10190886015162AGILITY® CERAMIC ROTH .022 UR2 +8°T +9°A BRACKETS
10190886015155AGILITY® CERAMIC ROTH .022 UL2 +8°T +9°A BRACKETS
10190886015148AGILITY® CERAMIC ROTH .018 UR1 +12°T +5°A BRACKETS
10190886015131AGILITY® CERAMIC ROTH .018 UL1 +12°T +5°A BRACKETS
10190886015124AGILITY® CERAMIC ROTH .022 UR1 +12°T +5°A BRACKETS
10190886015117AGILITY® CERAMIC ROTH .022 UL1 +12°T +5°A BRACKETS
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