SD447195

GUDID H980SD4471950

2.0MM TI2 SAGITTAL SPLIT PLATE 4 HOLE/29.6MM

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable
Primary Device IDH980SD4471950
NIH Device Record Key635638f1-c2b6-470c-bba4-4443d313c54b
Commercial Distribution Discontinuation2020-06-28
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberSD447.195
Catalog NumberSD447195
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587003924 [Primary]
HIBCCH980SD4471950 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


[H980SD4471950]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-06-29
Device Publish Date2015-09-14

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