LEGEND 38-2B34-0020

GUDID D788382B3400201

LMI RC 022 MBT6, UL 6-6, UHK3, LHK3,4

Gc Orthodontics America Inc.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal
Primary Device IDD788382B3400201
NIH Device Record Key3d586e92-3b8a-4b70-9dbd-3ecdb1e2968e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEGEND
Version Model Number38-2B34-0020
Catalog Number38-2B34-0020
Company DUNS063167128
Company NameGc Orthodontics America Inc.
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]
HIBCCD788382B3400201 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
EJFBRACKET, METAL, ORTHODONTIC
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 Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [LEGEND]

D78838261000200LEGEND LMIRC 022 L1&2 -6°T 0°A
D78838255000200LEGEND LMIRC 022 U5 -7°T 0°A
D78838254000200LEGEND LMIRC 022 U4 -7°T 0°A
D78838245D00200LEGEND LMIRC 022 LR5 -17°T 2°A HK
D78838245000200LEGEND LMIRC 022 LR5 -17°T 2°A
D78838244D00200LEGEND LMIRC 022 LR4 -12°T 2°A HK
D78838244000200LEGEND LMIRC 022 LR4 -12°T 2°A
D78838243D00200LEGEND LMIRC 022 LR3 -6°T 3°A HK
D78838235D00200LEGEND LMIRC 022 LL5 -17°T 2°A HK
D78838235000200LEGEND LMIRC 022 LL5 -17°T 2°A
D78838234D00200LEGEND LMIRC 022 LL4 -12°T 2°A HK
D78838234000200LEGEND LMIRC 022 LL4 -12°T 2°A
D78838233D00200LEGEND LMIRC 022 LL3 -7°T 9°A HK
D78838224D00200LEGEND LMIRC 022 UL4/5 -7°T 0°A HK
D78838223D00200LEGEND LMIRC 022 UL3 -7°T 9°A HK
D78838222000200LEGEND LMIRC 022 UL2 8°T 9°A
D78838221000200LEGEND LMIRC 022 UL1 17°T 4°A
D78838214D00200LEGEND LMIRC 022 UR4/5 -7°T 0°A HK
D78838213D00200LEGEND LMIRC 022 UR3 -7°T 9°A HK
D78838212000200LEGEND LMIRC 022 UR2 8°T 9°A
D78838211000200LEGEND LMI RC 022 UR1 17°T 4°A
D78838161000200LEGEND lLMI RC MBT 018/L1&2-6°T 0°A
D78838155000200LEGEND LMI RC 018/UR/UL4/5 -7°T 0°A
D78838154000200LEGEND LMI RC MBT 018/UR/UL4/5 -7°T
D78838145D00200LEGEND LMI RC MBT 018/LR5 -17°T 2°A HK
D78838145000200LEGEND LMI RC MBT 018/LR5 -17°T 2°A
D78838144D00200LEGEND LMI RC MBT 018/LR4 -12°T 2°A HK
D78838144000200LEGEND LMI RC MBT 018/LR4 -12°T 2°A
D78838143D00200LEGEND LMI RC MBT 018/LR3 -6°T 3°A 0OF HK
D78838135D00200LEGEND LMI RC MBT 018/LL5 -17T 2°A HK
D78838135000200LEGEND LMI RC MBT 018/LL5 -17°T 2°A
D78838134D00200LEGEND LMI RC MBT 018/LL4 -12T 2°A HK
D78838134000200LEGEND LMI RC MBT 018/LL4 -12°T 2°A
D78838133D00200LEGEND LMI RC MBT 018/LL3 -6°T 3°A 0OF HK
D78838124D00200LEGEND LMIRC 018 MBT UL4 -7°T 0°A HK
D78838123D00200LEGEND LMIRC 018 MBT UL3 -7°T 8°A HK
D78838122000200LEGEND LMIRC 018 MBT UL2 10°T 8°A
D78838121000200LEGEND LMIRC 018 MBT UL1 17°T 4°A
D78838114D00200LEGEND LMIRC 018 MBT UR4 -7°T 0°A HK
D78838113D00200LEGEND LMIRC 018 MBT UR3 -7°T 8°A HK
D78838112000200LEGEND LMIRC 018 MBT UR2 10°T 8°A
D78838111000200LEGEND LMIRC 018 MBT UR1 17°T 4°A
D78832X5441LEGEND MED VS 022 HK3 707
D78832X29911LEGEND LMED ROTH 018 HK 3,4,5
D78832S19911LEGEND MED HK34&5OB/LHK34&5OB
D78832LMI221LEGEND MED 022 MBT with LMI 2-2 HK3,4,5
D78832BID300341LEGEND LME BID VSLOT 018/022/U5-5/L5-5, 3HK
D788322CC500201LEGEND MEDIUM 022 MBT U5-5/L5-5 HK345
D788322CC500101LEGEND MEDIUM 022 ROTH U5-5/L5-5 HK345
D788322CC400201LEGEND LME MBT 022 U/L5-5 HK3,4

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