DISTRACTOR TOP HANDLE 101-0028

GUDID 00810097802438

DISTRACTOR TOP HANDLE

SMV SCIENTIFIC LLC

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• Primary Device ID: 00810097802438
• NIH Device Record Key: 05923827-9f3d-473d-9522-655686fba52a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTRACTOR TOP HANDLE
• Version Model Number: 101-0028
• Catalog Number: 101-0028
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC 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: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097802438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221332

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

[00810097802438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-25
• Device Publish Date: 2023-04-17

On-Brand Devices [DISTRACTOR TOP HANDLE]

• 00810097802445: DISTRACTOR TOP HANDLE
• 00810097802438: DISTRACTOR TOP HANDLE