0331106110

GUDID H67903311061100

NUT 10 PACK

SYNTHES (U.S.A.) LP

Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut

Primary Device ID	H67903311061100
NIH Device Record Key	6f658a8d-9173-4f85-b77a-c20a058c821f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	03.311.061.10
Catalog Number	0331106110
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
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
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	20886982078176 [Primary]
GS1	80886982078178 [Unit of Use]
HIBCC	H67903311061100 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K051600

FDA Product Code

KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT