12mm Sleeve 202-0102

GUDID 00810097801035

12mm Sleeve

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00810097801035
• NIH Device Record Key: a071d705-23c8-49b3-bae5-a7491953e0e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12mm Sleeve
• Version Model Number: 202-0102
• Catalog Number: 202-0102
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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
• 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: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810097801035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230226

FDA Product Code

• FZX: Guide, Surgical, Instrument
• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

[00810097801035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

On-Brand Devices [12mm Sleeve]

• 00810097800342: 12mm Sleeve
• 00810097801035: 12mm Sleeve