Erisma®-LP 18175555

GUDID 03700780618255

POLYAXIAL REDUCTION SCREW

CLARIANCE

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03700780618255
• NIH Device Record Key: 48835105-19dc-4348-bb2c-dd1b0d217d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-LP
• Version Model Number: 18175555
• Catalog Number: 18175555
• 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: true
• 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: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780618255 [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

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

[03700780618255]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [Erisma®-LP]

• 03700780638833: ROD HOLDER
• 03700780630165: DOUBLE BREAKING LEVER
• 03700780634385: POLYAXIAL REDUCTION SCREW
• 03700780618255: POLYAXIAL REDUCTION SCREW
• 03700780644056: ERISMA-LP CANNULATED SCREWDRIVER