498805

GUDID H6794988050

TI CERCLAGE BUTTON 4.5MM

SYNTHES (U.S.A.) LP

Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Internal orthopaedic fixation system, cerclage wire/cable, non-sterile Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw

Primary Device ID	H6794988050
NIH Device Record Key	52467f52-9788-4891-93c3-a455d77a7bb3
Commercial Distribution Status	In Commercial Distribution
Version Model Number	498.805
Catalog Number	498805
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	5
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	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
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
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
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	20886982236965 [Primary]
GS1	80886982236967 [Unit of Use]
HIBCC	H6794988050 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K992617

FDA Product Code

HTN	WASHER, BOLT NUT