OsteoCentric Proximal Humerus Plate 316-05-115

GUDID 00816950028007

Proximal Humerus Plate 5 Hole 115mm

SMV SCIENTIFIC LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950028007
• NIH Device Record Key: 192447ab-d700-4279-8cf0-3108e4985981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoCentric Proximal Humerus Plate
• Version Model Number: 316-05-115
• Catalog Number: 316-05-115
• 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: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@osteocentric.com
• Phone: 1-800-969-0639
• Email: info@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

• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter
• Length: 115 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950028007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190430

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

[00816950028007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [OsteoCentric Proximal Humerus Plate]

• 00816950028014: Proximal Humerus Plate 7 Hole 140mm
• 00816950028007: Proximal Humerus Plate 5 Hole 115mm
• 00816950027994: Proximal Humerus Plate 3 Hole 90mm