LCP 442507

GUDID H6794425070

2.4MM TI LCP(TM) DISTAL RADIUS L-PLATE/-90DEG 3H HD/4H SHAFT

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH6794425070
NIH Device Record Key2f2ac00b-4583-4d6a-9c4a-0744859aa9d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLCP
Version Model Number442.507
Catalog Number442507
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
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 Datefalse
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(800)255-2500
Emailxx@xx.xx
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982222992 [Primary]
HIBCCH6794425070 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794425070]

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[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

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[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

Moist Heat or Steam Sterilization


[H6794425070]

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[H6794425070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2015-09-14

On-Brand Devices [LCP]

H679031230110INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT
H679031230100INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/RT
07611819334458AIMING ARM F/LCP PROXIMAL HUMERUS PLATE
07611819391710COUPLING BOLT FOR LCP PERIARTICULAR AIMING ARMS
07611819979611STOPPER FOR LCP PERIARTICULAR AIMING ARMS-LARGE
07611819970144SCALPEL HANDLE F/LCP PERIART AIMING INSTRUMENT SET-LARGE
07611819970120LOCK NEUTRAL GUIDE FOR LCP PERIARTIC AIMING SYSTEM/LARGE
07611819978294PERIARTICULAR AIMING ARM F/4.5MM LCP CONDYLAR PLATE 8H
07611819978287PERIARTICULAR AIMING ARM F/4.5MM LCP CONDYLAR PLATE 18H
07611819978270PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT
07611819970113PERIARTICULAR INSERTION HANDLE F/4.5MM LCP CONDYLAR PL-LEFT
07611819978263PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-RT
07611819970007PERIARTICULAR INSERTION HANDLE F/4.5MM LCP CONDYLAR PL-RIGHT
07611819969995COUPLING BOLT F/OBLIQUE AIMING GUIDE F/LCP PERIART AIMING AR
07611819969988OBLQUE AIM GUIDE F/PERIART ARM F/4.5MM LCP PROX TIBIA PL-LT
07611819978256PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-LT
07611819969964OBLQUE AIM GUIDE F/PERIART ARM F/4.5MM LCP PROX TIBIA PL-RT
07611819978249PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT
07611819393981THREADED BENDING PIN FOR 1.5MM LCP PLATES
H6790311400101.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
07611819405394DEPTH GAUGE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
H679031130170STOPPER FOR 3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819348639PULL REDUCTION DEVICE F/3.5MM LCP PERCUTANEOUS INSTR SYS
07611819405387SCALPEL HANDLE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819334373TROCAR W/HANDLE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819403727AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/LEFT
07611819403703AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT
H679031119050SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE
07611819412880OSTEOTOMY MEASURING DEVICE FOR 2.7MM PEDIATRIC LCP HIP PL
07611819412767PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 2.7MM SCREWS
07611819888876MEDIALIZATION GUIDE FOR 3.5MM & 5.0MM LCP PLATES
07611819847224PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS
07611819847217PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS
H67902161290S03.5MM CURVED BROAD LCP PLATE/30 HOLE-STERILE
H6790216129003.5MM CURVED BROAD LCP PLATE/30 HOLE
H67902161288S03.5MM CURVED BROAD LCP PLATE/28 HOLE-STERILE
H6790216128803.5MM CURVED BROAD LCP PLATE/28 HOLE
H67902161286S03.5MM CURVED BROAD LCP PLATE/26 HOLE-STERILE
H6790216128603.5MM CURVED BROAD LCP PLATE/26 HOLE
H67902161284S03.5MM CURVED BROAD LCP PLATE/24 HOLE-STERILE
H6790216128403.5MM CURVED BROAD LCP PLATE/24 HOLE
H67902161282S03.5MM CURVED BROAD LCP PLATE/22 HOLE-STERILE
H6790216128203.5MM CURVED BROAD LCP PLATE/22 HOLE
H67902161280S03.5MM CURVED BROAD LCP PLATE/20 HOLE-STERILE
H6790216128003.5MM CURVED BROAD LCP PLATE/20 HOLE
H67902161278S03.5MM CURVED BROAD LCP PLATE/18 HOLE-STERILE
H6790216127803.5MM CURVED BROAD LCP PLATE/18 HOLE
H67902161276S03.5MM CURVED BROAD LCP PLATE/16 HOLE-STERILE
H6790216127603.5MM CURVED BROAD LCP PLATE/16 HOLE
H67902161274S03.5MM CURVED BROAD LCP PLATE/14 HOLE-STERILE

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