DCP 449032

GUDID H9804490320

2.0MM TI ANGLED DCP PLATE 4 X 4 HOLES/21MM X 21MM

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable
Primary Device IDH9804490320
NIH Device Record Key9285b77f-4d48-4eef-824f-e738207602d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDCP
Version Model Number449.032
Catalog Number449032
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 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
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
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
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
GS110887587054049 [Primary]
HIBCCH9804490320 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


[H9804490320]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

On-Brand Devices [DCP]

H98044903802.0MM TI DCP PLATE 8 HOLES/54MM
H98044903702.0MM TI DCP PLATE 7 HOLES/48MM
H98044903602.0MM TI DCP PLATE 6 HOLES/42MM
H98044903502.0MM TI DCP PLATE 5 HOLES/32MM
H98044903402.0MM TI DCP PLATE 4 HOLES/30MM
H98044903202.0MM TI ANGLED DCP PLATE 4 X 4 HOLES/21MM X 21MM
H9804435802.0MM TI MF DCP PLATE 8 HOLES/42MM
H9804435702.0MM TI MF DCP PLATE 7 HOLES/37MM
108875870510482.0MM TI MF DCP PLATE 6 HOLES/32MM
108875870510312.0MM TI MF DCP PLATE 5 HOLES/27MM
H9804435402.0MM TI MF DCP PLATE 4 HOLES/22MM
H67944402202.7MM TI DCP® PLATE 2 HOLES/26MM
H67944401202.7MM TI DCP® PLATE 12 HOLES/100MM
H67944401002.7MM TI DCP® PLATE 10 HOLES/84MM
H67944400902.7MM TI DCP® PLATE 9 HOLES/76MM
H67944400802.7MM TI DCP® PLATE 8 HOLES/68MM
H67944400702.7MM TI DCP® PLATE 7 HOLES/60MM
H67944400602.7MM TI DCP® PLATE 6 HOLES/52MM
H67944400502.7MM TI DCP® PLATE 5 HOLES/44MM
H67944400402.7MM TI DCP® PLATE 4 HOLES/36MM
H67944400202.7MM TI DCP® PLATE 2 HOLES/20MM
H67944305802.0MM TI DCP® PLATE 8 HOLES/42MM
H67944305702.0MM TI DCP® PLATE 7 HOLES/37MM
H67944305602.0MM TI DCP® PLATE 6 HOLES/32MM
H67944305502.0MM TI DCP® PLATE 5 HOLES/27MM
H67944305402.0MM TI DCP® PLATE 4 HOLES/22MM
H6792435802.0MM DCP® PLATE 8 HOLES/42MM
H6792435702.0MM DCP® PLATE 7 HOLES/37MM
H6792435602.0MM DCP® PLATE 6 HOLES/32MM
H6792435502.0MM DCP® PLATE 5 HOLES/27MM
H6792435402.0MM DCP® PLATE 4 HOLES/22MM
H6793224404.5MM DCP® DRILL GUIDE NEUTRAL & LOAD
H6793224304.5MM DCP® HIP DRILL GUIDE NEUTRAL & LOAD 60MM
H6793223203.5MM DCP® DRILL GUIDE NEUTRAL & LOAD
H6793222102.7MM DCP® DRILL GUIDE NEUTRAL & LOAD
H6793221502.0MM DCP® DRILL GUIDE NEUTRAL & LOAD
H6792442202.7MM DCP® PLATE 2 HOLES/26MM
H6792441202.7MM DCP® PLATE 12 HOLES/100MM
H6792441002.7MM DCP® PLATE 10 HOLES/84MM
H6792440902.7MM DCP® PLATE 9 HOLES/76MM
H6792440802.7MM DCP® PLATE 8 HOLES/68MM
H6792440702.7MM DCP® PLATE 7 HOLES/60MM
H6792440602.7MM DCP® PLATE 6 HOLES/52MM
H6792440502.7MM DCP® PLATE 5 HOLES/44MM
H6792440402.7MM DCP® PLATE 4 HOLES/36MM
H6792440202.7MM DCP® PLATE 2 HOLES/20MM
H6792482203.5MM DCP PLATE 22 HOLES/265MM
H6792482003.5MM DCP PLATE 20 HOLES/242MM
H6792480503.5MM DCP PLATE 5 HOLES/61MM
H6792480303.5MM DCP PLATE 3 HOLES/37MM

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