EXPEDIUM VIPER 196789300

GUDID 10705034295251

EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 300mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system rod
Primary Device ID10705034295251
NIH Device Record Key7f1fad13-1feb-4200-833f-f307976613fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPEDIUM VIPER
Version Model Number196789300
Catalog Number196789300
Company DUNS107105876
Company NameDEPUY SPINE, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034295251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


[10705034295251]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2015-09-24

On-Brand Devices [EXPEDIUM VIPER]

10705034295282EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 600mm
10705034295275EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 480mm
10705034295268EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 400mm
10705034295251EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 300mm
10705034295244EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 200mm
10705034295237EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 120mm
10705034182537EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 x 120mm

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