SD03127008

GUDID 10886982335517

INSERTION HANDLE PROX TIBIA VA-LCP SMALL BEND PLATE-LT

SYNTHES (U.S.A.) LP

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Primary Device ID	10886982335517
NIH Device Record Key	0fc70664-d2b6-420d-b186-68e90986d4e0
Commercial Distribution Status	In Commercial Distribution
Version Model Number	SD03.127.008
Catalog Number	SD03127008
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982335517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120689

FDA Product Code

HRS	Plate, fixation, bone