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 ID: 10705034295251
• NIH Device Record Key: 7f1fad13-1feb-4200-833f-f307976613fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPEDIUM VIPER
• Version Model Number: 196789300
• Catalog Number: 196789300
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034295251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090648

FDA Product Code

• OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2015-09-24

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• 10705034295268: EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 400mm
• 10705034295251: EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 300mm
• 10705034295244: EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 200mm
• 10705034295237: EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 x 120mm
• 10705034182537: EXPEDIUM and VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 x 120mm