8.0mm Drill Bit Cannulated 317-0010

GUDID 00816950029417

8.0mm Drill Bit Cannulated

SMV SCIENTIFIC LLC

Fluted surgical drill bit, reusable

• Primary Device ID: 00816950029417
• NIH Device Record Key: a98af1b3-9874-48a3-a487-b0bc54109627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8.0mm Drill Bit Cannulated
• Version Model Number: 317-0010
• Catalog Number: 317-0010
• 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

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950029417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210247

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

[00816950029417]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-17
• Device Publish Date: 2021-05-07

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