LCP 03111903

GUDID H679031119030

DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/4.0MM

SYNTHES (U.S.A.) LP

Surgical drill guide, reusable
Primary Device IDH679031119030
NIH Device Record Key76d9bc99-0169-41cb-a6f9-e9139be98d0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLCP
Version Model Number03.111.903
Catalog Number03111903
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 Usefalse
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819414488 [Direct Marking]
GS110886982072610 [Primary]
HIBCCH679031119030 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

[H679031119030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-06
Device Publish Date2015-09-14

On-Brand Devices [LCP]

07611819374362BENDING TEMPLATE/16 HOLES 4.5MM/5.5MM LCP & LC-DCP PLATE
H679238711S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 14H/LT-STER
H679238710S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 14H/RT-STER
H679238709S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 12H/LT-STER
H679238708S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 12H/RT-STER
H679238707S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 10H/LT-STER
H679238706S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 10H/RT-STER
H679238705S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 8H/LT-STER
H679238704S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 8H/RT-STER
H679238703S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 6H/LT-STER
H679238702S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 6H/RT-STER
H679238701S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 4H/LT-STER
H679238700S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL W/O TAB 4H/RT-STER
H67904110851S0OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/5H SHAFT/LT-STERILE
H67904110850S0OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/5H SHAFT/RT-STERILE
H67904110841S0OI LCP VOLR CLMN DSTL RADIUS PL 7H HEAD/4H SHAFT/LT-STERILE
H67904110751S0OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/5H SHAFT/LT-STERILE
H67904110741S0OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/4H SHAFT/LT-STERILE
H67904110740S0OI LCP VOLR CLMN DSTL RADIUS PL 6H HEAD/4H SHAFT/RT-STERILE
076118192485025.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE
076118192466074.3MM THREADED LCP(TM) DRILL GUIDE
07611819274105THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES
076118191740162.0MM LCP SOLID THREADED DRILL GUIDE
07611819348714INSERTION HANDLE F/LCP PROX HUMERUS PLATE/STARDRIVE
H6790312200102.8MM LCP(TM) DRILL GUIDE-LONG FOR 3.5MM LCP(TM) PLATES
07611819969971PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-L
07611819969957PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-R
07611819334397COMPRESSION DRILL GUIDE F/3.5 MM LCP PERCUTANEOUS INSTR SYS
07611819334380NEUTRAL DRILL GUIDE F/3.5MM LCP PERCUTANEOUS INSTR SYS
07611819334366OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
H679031119040DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/5.0MM
H679031119030DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/4.0MM
H679031119020DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/3.0MM
H679031119010DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.5MM
H679031119000DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.0MM
076118196047351.8MM LCP SOLID THREADED DRILL GUIDE FOR 2.4MM LCP PLATES
076118196047281.5MM LCP SOLID THREADED DRILL GUIDE FOR 2.0MM LCP PLATES
076118194128282.0MM THREADED DRILL GUIDE FOR 2.7MM PEDIATRIC LCP HIP PL
076118198889064.3MM THREADED DRILL GUIDE FOR 5.0MM PEDIATRIC LCP HIP PL
076118198888902.8MM THREADED DRILL GUIDE FOR 3.5MM PEDIATRIC LCP HIP PL
H679239921S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 14H/246MM LT-STER
H679239920S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 14H/246MM RT-STER
H679239917S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 12H/220MM LT-STER
H679239916S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 12H/220MM RT-STER
H679239913S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 10H/194MM LT-STER
H679239912S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 10H/194MM RT-STER
H679239909S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 8H/168MM LT-STER
H679239908S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 8H/168MM RT-STER
H679239905S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 6H/142MM LT-STER
H679239904S03.5MM LCP(TM) MEDIAL DISTAL TIBIA PL 6H/142MM RT-STER
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