Drill Sleeve 2004-0001-03

GUDID 00816950027833

Drill Sleeve

SMV SCIENTIFIC LLC

Surgical drill guide, reusable

• Primary Device ID: 00816950027833
• NIH Device Record Key: 19b37bd4-3413-4832-92aa-8a4d556a20c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Sleeve
• Version Model Number: 2004-0001-03
• Catalog Number: 2004-0001-03
• 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: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950027833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170021

FDA Product Code

• FZX: Guide, Surgical, Instrument
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

[00816950027833]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-12
• Device Publish Date: 2020-06-17

On-Brand Devices [Drill Sleeve]

• 00816950027833: Drill Sleeve
• 00816950028038: Drill Sleeve