Rod Gripper 99715013

GUDID 03700780637881

Spinal instrument

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780637881
• NIH Device Record Key: a8b553cd-71d0-4108-a4aa-aa6fdbee2da5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rod Gripper
• Version Model Number: 99715013
• Catalog Number: 99715013
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: true
• 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: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us
• Phone: 1 773 620 2111
• Email: s.chambat@clariance-spine.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780637881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153326

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

[03700780637881]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-10-19

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• 03700780605026 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605033 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605040 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605057 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605064 - Erisma™-LP: 2024-12-19 Monoaxial screw
• 03700780605071 - Erisma™-LP: 2024-12-19 Monoaxial screw